|
Advanced Clinical Pharmacology
|
Kings College London
|
Centre of Excellence |
United Kingdom |
Kings College London
Kings Building,
Wc2r 2ls London
United Kingdom
Contact
Programme Officer
+44 (0)20 7848 4684
e-Mail
External Links
Course Description
Over four days this module provides advanced training in the principles of clinical pharmacology essential to drug development. This includes practical and ethical issues associated with non-patient volunteer studies, the design of such studies and interpretation of the results. Completion of this module will enable you to take an active role in a multidisciplinary team to design and analyse clinical pharmacology studies.
Key topics include: Non-patient volunteer studies, planning a clinical development strategy, use of pharmacodynamic and pharmacokinetic measures in clinical pharmacology studies, statistical principles used in clinical pharmacology studies.
You will take part in practical sessions to plan a clinical development strategy for a potential new medicine, prepare a study protocol, analyse study results and learn how to present clinical pharmacology study results through both verbal and written presentations.
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Advanced Quantitative Benefit-Risk Assessment Methods in Decision Making On Medicines
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development. This module will address the decision-making on medicines by different stakeholders and how to apply advanced benefit-risk assessment tools in this process.
Topics covered include:
Multi-criteria decision analysis
Conjoint analysis
Personalized benefit-risk assessment
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Arzneimittelzulassung fuer Einsteiger/EU-Zulassung fuer Einsteiger
|
FORUM Institut für Management GmbH
|
Centre of Excellence |
Germany |
FORUM Institut für Management GmbH
Vangerowstrasse 18
69115 Heidelberg
Germany
Contact
Tatjana Mende
49 6221 500 565
e-Mail
External Links
Course
Office
Course Description
Dieser Einsteigerlehrgang macht Sie fit fuer alle operativen Aufgaben in Regulatory Affairs. Sie lernen die Details der Zulassungsverfahren in Europa. Sie kennen anschliessend die notwendigen Zulassungsunterlagen sowie die Herausforderungen bei der Kompilierung. Ihre Aufgaben im Lifecycle-Management koennen Sie dabei in einigen praktischen Uebungen trainieren.
Learning Outcomes
Nach Lehrgangsende kennen Sie die Zulassungsverfahren in Europa. Sie kennen die Prozessanforderungen in den Zulassungsverfahren und die zugehoerigen Fristen. Sie sind in der Lage, das passende Zulassungsverfahren zum eigenen Produkt zu waehlen. Sie koennen den Einreichungs- und Verfahrensprozess begleiten. Sie kennen die Besonderheiten generischer Einreichungen. Sie koennen die notwendigen Zulassungsunterlagen zusammenstellen (Q, E, S). Sie wissen den Aufbau von SmPC und Packungsbeilage. Sie verstehen die Prinzipien der elektronischen Einreichung. Sie kennen die Erfordernisse des Lifecycle-Managements und haben das Aenderungsmanagement an vielen praktischen Beispielen geuebt.
Scientific Areas
Wenn Sie in Regulatory Affairs arbeiten oder in der Zusammenarbeit mit der Zulassungsabteilung regulatorisches Know-how brauchen, dann ist dieser Lehrgang fuer Sie geeignet. Ein Vorbereitungs-e-Learning wird Ihnen 2 Wochen vor Start der Live-Online-Seminare zugesandt, um Sie optimal vorzubereiten.
Language
German
Next Course Start Date
Contact course provider
Scholarship available
No
Course Location
Online Germany
|
Assessment and Medical Evaluation of Individual Case Safety Reports
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Course Description
Our Assessment and Medical Evaluation of Individual Case Safety Reports is an interactive course designed to provide delegates with the necessary skills and knowledge required to assess individual case safety reports. You will assess reports from various sources both from a regulatory and a clinical perspective. Evaluation of a cluster of reports or case series will be discussed, in addition to guidance regarding the coding of certain types of events such as off label use. The course covers the current and future requirements for the production of case narratives, at an individual level and also within regulatory submissions such as periodic benefit risk evaluation reports. Practical coaching takes place in small groups where delegates have the opportunity to discuss individual cases and receive feedback from expert tutors.
Outline:
- Overview of data elements required for case narrative writing
- Style and skill involved
- Handling follow-up information
- Dealing with difficult cases and special situations
- Incorporating narratives into; Individual Case Safety Reports clinical trial study reports, periodic safety reports, regulatory summaries and research reports
- Practical exercises in writing case narratives
- Case narratives in the future, including 'auto-narratives'
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
- Relate the complexity of medical history taking into account challenges faced in producing good quality case narratives
- Define and appraise the critical data elements needed from reporting sources to complete a safety report
- Critically analyse an individual adverse event as to whether it is reportable and provide recommendations as to whether reporting should be expedited
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
United Kingdom
|
Ausbildung Zum Drug Safety Manager
|
FORUM Institut für Management GmbH
|
Centre of Excellence |
Germany |
FORUM Institut für Management GmbH
Vangerowstrasse 18
69115 Heidelberg
Germany
Contact
Dr. Henriette Wolf-Klein
49 (0)6221 500 680
e-Mail
External Links
Course
Office
Course Description
Um aktuelle und zukuenftige Herausforderungen in der Pharmakovigilanz zu meistern, benoetigt die Pharmaindustrie topausgebildete Mitarbeitende, die als Drug Safety Manager anspruchsvolle Taetigkeiten uebernehmen koennen. Nehmen Sie teil an dem Streifzug durch die unterschiedlichen Bereiche der Pharmakovigilanz. Anschliessend haben Sie einen umfassenden Einblick in die verschiedenen Verantwortungsbereiche einer modernen Pharmakovigilanzabteilung erhalten und besitzen das noetige Ruestzeug fuer die taegliche Arbeit in der Arzneimittelsicherheit.
Learning Outcomes
In zweimal zwei Tagen stellen Ihnen unsere Expertinnen und Experten aus Pharmaindustrie, Bundesoberbehoerde und Beratung alle relevanten Teilbereiche der Pharmakovigilanz vor. Sie lernen alle wichtigen Positionen, Aufgaben und Verantwortlichkeiten der Drug Safety kennen und verlassen den Lehrgang mit dem notwendigen Wissen, um gut vorbereitet Ihre Taumltigkeit in der Pharmakovigilanz aufzunehmen. Zusaetzlich zu den Live-Vortraegen erhalten Sie Zugang zu unserem e-Learning Basiswissen Pharmakovigilanz. Um die Nachhaltigkeit des Lehrganges sicherzustellen und um Ihr Wissen zu dokumentieren, schliessen Sie den Lehrgang mit einem Online-Test ab. Dieser kann bis zu zwei Wochen nach Ende des Lehrgangs virtuell absolviert werden. Taegliche Wrap-Ups zu den Themen des Tages werden Sie auf den Test vorbereiten und das Erlernte festigen.
Scientific Areas
Dieser Online-Lehrgang richtet sich an Mitarbeitende der pharmazeutischen Industrie ohne oder mit wenig Erfahrung in der Pharmakovigilanz, die sich zum Drug Safety Manager weiterentwickeln moechten.Auszligerdem richtet sich der Lehrgang an Studierende hoehrer Semester medizinischer/naturwissenschaftlicher Faecher, die Ihren Einstieg in das Berufsleben planen sowie junge Berufstaetige mit medizinisch/naturwissenschaftlichem Background, die mit diesem Lehrgang ihren Einstieg in die Pharmakovigilanzabteilung eines pharmazeutischen Unternehmens vorbereiten moumlchten.
Language
German
Course Length
4 (twice two days) Day(s)
Next Course Start Date
Contact course provider
Scholarship available
No
Course Location
Online Germany
|
Back to Basics in Pharmacovigilance
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Monitoring drug safety is very important to public health. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Those working in pharmacovigilance must have good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management. This course provides solid practical foundations for those working in drug safety, and an update for experienced staff. This course will be valuable not only to those working directly in pharmacovigilance but to a broad range of staff across the pharmaceutical industry and regulatory authorities.
Aims
- To provide delegates with a historical perspective of pharmacovigilance -
- To explore the principles of causality -
- To ensure an understanding of basic terminology and provide definitions of key concepts -
- To introduce delegates to current key regulatory requirements, both local and international -
- To introduce delegates to the concept of benefit risk in pre-marketing development -
- To provide an awareness of the evolution of systems of reporting
Programme features
- Historical aspects and evolution of drug safety -
- Regulatory aspects, including the Clinical Trial Directive and PDUFA III -
- International Conferences on Harmonisation -
- Collecting and reporting drug safety information -
- Pharmacovigilance planning
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completion of the course delegates should be able to:
- Critically appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue
- Explain key operational drug safety definitions
- Demonstrate good pharmacovigilance practice and locate key sources of information and documentation
- Critically discuss issues associated with global pharmacovigilance
- Analyse the stages of drug development in terms of drug safety assessment and benefit risk
- Critically explain the strengths and weakness of pharmacovigilance reporting systems
- Identify and predict future challenges in drug safety and pharmacovigilance
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Fareham United Kingdom
|
Basics in Clinical Pharmacology
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives
To understand the role of medicines in therapeutics, health services and society
To become familiar with the life cycle of medicines and the regulatory aspects of medicines market
To review the clinical and pharmacological basis of prescribing
To understand the need to evaluate the effects of medicines from an epidemiological perspective
To understand the relevance of unbiased information to ensure the appropriate use of medicines
To discuss the need to monitor medicines prescribing process
Topics
Clinical pharmacology. Aims and uses in the therapeutics.
Clinical pharmacology and epidemiological evaluation of medicine effects
The randomized clinical trials (RCT) as a method for assess the efficacy of medicines
Basics for RCT appraisal: extrapolation of RCTs results to clinical practice.
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Basics in Epidemiology Applied to Pharmacovigilance and Pharmacoepidemiology
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives
To understand the basic concepts and principles in epidemiology
To become familiar with the epidemiological tools that could be used in pharmacovigilance and pharmacoepidemiology
To understand the specificity of epidemiological tools applied to pharmacovigilance and pharmacoepidemiology
Topics covered:
Descriptive epidemiology (person, place and time)
Observational studies in pharmacoepidemiology
Biases in pharmacoepidemiology studies
Causality criteria, evidence level and critical reading
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Basics in Health Economics E-Learning
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
41 61 267 19 52
e-Mail
External Links
Course
Office
Course Description
This e-learning course provides an understanding of the key principles and methodological concepts of health economic evaluations. It is based on the well-established face-to-face course on health economics offered by the ECPM. The scientific content was developed by Prof. Thomas Szucs and Prof. Matthias Schwenkglenks as well as other specialists from the field.
Learning Outcomes
At the end of the course, the participants should be able to describeFundamental concepts of health economicsKey elements of health economic evaluationAssessment and analysis of a published health economic studyThe importance of health economic/pharmacoeconomic methods and concepts for the drug development process, clinical trials, and post-marketing surveillanceHow policymakers set priorities in health care and how health economic evaluations support this process
Language
English
Course Length
1 Hour(s)
Next Course Start Date
Anytime
Scholarship available
No
Course Location
Basel Switzerland
|
Basics in Medicines Risk Communication
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives
To know the basic principles of communication and to gain an insight into the characteristics of effective communication
To face to the complexity communication on risk for health
To know the evolution of medicine risk communication
Topics covered:
Which knowledge and skills are useful for communication?
Concrete examples of communication: what do we retain?
Why communicate? Nature and importance of communication. Personal and social dimension of communication
Face to face between doctor and patient. How to find the right word?
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Basics in Pharmacoepidemiology
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives :
To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use
To know the main methodological and ethical characteristics and limitations of randomized clinical trials
To understand the differences between efficacy and effectiveness
To know the basic concepts and classification of the pharmacoepidemiological studies designed to evaluate therapeutic interventions
To identify information gaps in selected therapeutic areas (e.g. cardiovascular, psychiatry, diabetes care)
Topics covered:
Patients, medicines and prescribing in society. Life cycle of medicines.
The knowledge-building process of the effects and adverse effects of medicines during their development and clinical use.
Overview of studies to detect and to evaluate the risk associated with therapeutic interventions. Scope, uses and limitations.
The need to monitor the medicines prescribing process.
Introduction to the study of the use of medicines in clinical practice.
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Basics in Statistics Applied to Pharmacovigilance and Pharmacoepidemiology
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives
To understand applications of probability in statistics
To understand how to organize and describe epidemiological data
To understand how to perform data estimations, comparisons and predictions
To understand how to estimate the sample size and power of epidemiology studies
To introduce the principles of multivariable comparisons
Topics covered:
Introduction to statistics and probability
Estimates
Statistical testing
Introduction to multivariable linear regression
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Best Practices for Data Supervisors in Pharmacovigilance Virtual Live Training Course
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
BIOLOGICAL MEDICINAL PRODUCTS AND ADVANCED THERAPIES
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Ms. Judit Lendvay, Course Manager; Dr. Sandor Kerpel-Fronius, Course Director
+36304757366
e-Mail
External Links
Course
Course Description
The students will receive an update on molecular biology and immunology needed for understanding the development of biological and advanced medicinal products as well as vaccines. The development, application, and regulatory requirements of these medicinal products will be discussed in detail.
Learning Outcomes
1. Demonstrate an understanding of the scientific, regulatory, ethical and legal issues that are peculiar to biological and advanced therapies.
2. Demonstrate an understanding of the challenges presented in constructing a package of non-clinical data to support the clinical development and marketing of biological and advanced therapies.
3. Recommend a clinical trial plan that is appropriate for the different types of products and technologies represented by biological and advanced therapies.
4. Demonstrate an understanding of the technical and manufacturing issues that are peculiar to biological and advanced therapies.
5. Critically review the non-clinical and clinical scientific knowledge underlying the development of new or prospective biological or advanced therapies.
6. Describe the new technologies now available and those in development; describe the therapeutic opportunities that might arise from the technology.
7. Critically analyse the differences between natural and modified protein constructs.
8. Describe the global need for new and improved vaccines and the barriers to their development.
9. Discuss the history and future prospects for gene therapy, and the technical difficulties developing a gene therapy product.
10. Describe the concept of stem cell therapy, what opportunities it might present, and the ethical issues that are unique to this technology.
11. Describe the particular ethical and regulatory issues of advanced therapies and how The Advanced Therapy Directive is addressing these.
12. Demonstrate the understanding of the basic principles of the development of medical devices. Assess the scientific and regulatory issues relevant to the clinical development of medical device-drug combinations.
Scientific Areas
Medicines development
Language
English
Course Length
4 days
Next Course Start Date
February 07-10, 2019
Scholarship available
No
Course Location
Budapest Hungary
|
Case Studies in Medicines Risk Communication
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To analyse and discuss notable examples with special attention to the risk communication aspects
To analyse the role of media, internet, scientific journals, independent bulletin of information
To measure the effectiveness of risk communication as a minimisation strategy and consider ways of improving its effectiveness
Topics covered:
Hepatitis B vaccine in France, pandemic influenza vaccines, HRT and cancer. What can we learn? What could have been done?
Communication aspects based on drug withdrawals: e.g. rofecoxib, rosiglitazone, benfluorex. What can we learn? What could have been done?
How to measure the effectiveness of risk communication
Language
(Afan)/Oromoor/Oriya
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Clinical and Pharmacological Principles
|
Eu2P
|
PharmaTrain Centre |
Turks and Caicos Islands |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives:
To analyse and discuss the role and the impact of medicines in therapeutics, health services and society.
To understand the pharmacological and clinical essential principles of prescribing.
To understand the pharmacological, clinical and epidemiological principles underlying the effects (both beneficial and unwanted) of medicines in various populations.
To analyse and discuss the relevance of unbiased, updated information for prescribing.
To discuss and practice the selection of medicines for patients with specific disease.
To discuss and analyse the need to keep studying the effects of medicines in populations in general medical practice.
Topics covered:
Patients' therapeutic needs, medicines and society.
Patients, physicians, information and prescribing.
Clinical and pharmacological basis of therapeutics.
Variability in medicines response.
Therapeutics and medicines prescribing of medicines for selected health problems.
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
Turks and Caicos Islands
|
Clinical Drug Development
|
Kings College London
|
Centre of Excellence |
United Kingdom |
Kings College London
Kings Building,
Wc2r 2ls London
United Kingdom
Contact
Programme Officer
+44 (0)20 7848 4684
e-Mail
External Links
Course
Fees
Office
Course Description
This module covers the development of a new medicine from early exploratory clinical development right through to the stage of applying for a licence for marketing. We will highlight practical issues associated with running clinical trials, including large-scale multinational projects.
Key topics include: Clinical trial design, clinical end points, writing a protocol, project management, ethical and legal aspects of clinical research, logistics issues in clinical trials, clinical trials in children, data gathering for phase 2-4 studies, adverse events in clinical trials.
You will take part in workshop sessions and practical exercises to “develop†a new molecule and learn how to apply the principles of statistics to clinical trial design.
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Clinical Research MSc.
|
Donau-Universität Krems (UWK)
|
Centre of Excellence |
|
Donau-Universität Krems (UWK)
Zentrum für Gesundheitswissenschaften und Medizin
3500 Krems
Austria
Contact
External Links
|
Clinical Statistics for Non-Statisticians
|
Drug Information Association
|
PharmaTrain Centre |
Switzerland |
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
Krisztina Nemeth
+41 61 225 51 40
e-Mail
External Links
Course
Office
Course Description
Get a solid understanding of basic statistical concepts fundamental to clinical research, in a course for professionals who have regular exposure to statistics either through studies or professional experience.
Language
English
Course Length
2 days
Next Course Start Date
7 October 2019
Scholarship available
No
Course Location
Basel Switzerland
|
Communicating more Powerfully and Persuasively
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
This course is an intense two-day interactive, hands-on program designed to build and expand essential presentation skills from both content and delivery perspectives. Participants will learn how to improve their personal communication skills, their ability to develop targeted, compelling and memorable presentations, and to handle difficult questions from stakeholders.Participants should come ready to deliver a ten-minute presentation as well as a short story about a project in which they have been involved. Crucially, the story must include the type of obstacles that were faced, how they were overcome, the people or factors that helped or hindered along the way, together with the successes and failures and the outcome. Feedback from peers and the facilitators will help participants improve their ability to connect from both content and delivery perspectives.nbsp
Learning Outcomes
By the end of the course, participants will have a better understanding of how toPresent in a more compelling way to internal and external stakeholders with increased confidence and capabilityUse skills and techniques toTranslate complex concepts into scalable and tailored messages for stakeholdersDevelop engaging narratives using storytelling models that showcase and differentiate their science/projectSpeak effectively to groups of any size face-to-face and onlineConfidently handle question and answer sessionsnbsp
Language
English
Course Length
2 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Cooperative European Medicines Development Course (CEMDC)
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Study Manager: Ms. Judit Lendvay, Mob: +36304757366;
Ms. Judit Lendvay, Mob: +36304757366
e-Mail
External Links
Course
Course Description
Module 7: BIOLOGICAL MEDICINAL PRODUCTS AND ADVANCED THERAPIES, February 7-10, 2019
Module 8: FOLLOW-ON DRUGS: GENERIC, BIOSIMILAR & NON-BIOLOGICAL, May 16-19, 2019
See full program at the CEMDC website: http://semmelweis.hu/CEMDC
Learning Outcomes
See LOs at the website
Scientific Areas
Pharmaceutical Medicne, medinces development.
Therapeutic Areas
Pharmaceutical Medicine
Language
English
Course Length
Course 4 ongoing. Will be finished end of May, 2019
Next Course Start Date
Ongoing. Can register for individual modules: Module 7 Advanced medicinal products; February 7-10, 2019; Follow-on generic, biosimilar products, May 16-19, 2019
Scholarship available
No
Course Location
Budapest, Hungary Hungary
|
Critical Appraisal of Clinical Trials: Evidence-Based Medicine and Its Uncertainties
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To analyse and discuss strengths and limitations of randomised clinical trials and other epidemiological studies.
To analyse and discuss strengths and limitations of evidence-based medicine.
To undertake complete critical appraisals of different randomised clinical trials and meta-analysis of randomised clinical trials.
To identify the essential questions that remain to be studied for a given health problem.
To translate a therapeutic uncertainty into a research hypothesis and a research study protocol.
Topics covered:
Randomised clinical trials limitations.
Evidence-based medicine and its limitations.
Critical appraisal of randomised clinical trials limitations.
Critical appraisal of a meta-analysis of randomised clinical trials.
From therapeutic uncertainty to a research protocol
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Drug Regulatory Affairs
|
Kings College London
|
Centre of Excellence |
United Kingdom |
Kings College London
Kings Building,
Wc2r 2ls London
United Kingdom
Contact
Programme Officer
+44 (0)20 7848 4684
e-Mail
External Links
Course
Fees
Office
Course Description
This module explores the principles that underpin drug regulation in the UK and worldwide. Over four days, we will consider the regulatory requirements for special patient populations, commercial issues from product life cycle development through to marketing, pharmacovigilance, and the handling of off label and unlicensed medicines.
Key topics include: European regulatory procedures, ethics committees, adverse drug reaction reporting, regulatory requirements in special populations (eg, children, the elderly), advertising, internet sales, medical aspects of the Marketing Authorisation, bioequivalence and generics, special licensing issues (such as for biologicals, devices, herbal and homoeopathic medicines), and pharmacovigilance (pre- and post-marketing)
You will take part in a series of workshops to learn about practical aspects of Clinical Trial Authorisations, preparation of Summaries of Product Characteristics and Patient information leaflets, risk minimisation, and reclassification of the legal status of medicines.
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Drug Safety and Pharmacovigilance E-Learning
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
41 61 267 19 52
e-Mail
External Links
Course
Office
Course Description
This e-learning course provides an understanding of the safety-related aspects within the drug development process. These range from early preclinical testing, risk/benefit assessment up to clinical adverse event signal detection and monitoring.
Learning Outcomes
At the end of the course, the participants should be able to describeThe role of drug safety in the successful development and usage of a medicine to the benefit of patientsWhich safety-related questions need to be answered in early and late drug developmentTools, techniques, and methodologies used in drug safety evaluationWhat frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launchHow changes in safety assessment could become part of a new drug development paradigm
Language
English
Course Length
1 Hour(s)
Next Course Start Date
Anytime
Scholarship available
No
Course Location
Basel Switzerland
|
Drug Utilisation Studies: Introduction and Quantitative Methods
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives:
To understand the need to study how medicines are used.
To describe the general characteristics of the different methods to study the use of medicines, and to identify them.
To know the different methods and measures that allow quantitative approach to medicines utilisation.
To carry out critical appraisal of quantitative drug utilisation studies.
To design, to carry out and to analyze quantitative studies of medicines utilisation in different clinical settings.
Topics covered:
Measurement of drug use
Overview of drug utilisation studies (DUS)
Quantitative measures of drug utilisation.
Design of quantitative DUS
How to read papers on quantitative DUS
Language
(Afan)/Oromoor/Oriya
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Drug Utilisation Studies: Qualitative Methods
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To understand the need to design and to carry out qualitative drug utilisation research.
To be able to critically appraise qualitative drug utilisation studies (DUS).
To design, to implement and to discuss small-scale audits on the quality of medicines use in hospitals and in primary health care.
Topics covered:
Sources of data and standards to compare with.
Methods to identify how medicines are used in the community (1) - prescription vs. indication and indication vs. prescription
Methods to identify how medicines are used in the community (2) - cohort and case-controls studies as a source of drug utilisation data
Design of qualitative DUS: Objectives, methods and discussion of proposals
How to read papers on qualitative DUS. Limitations of DUS
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Economics of Healthcare
|
University of Duisburg-Essen
|
Centre of Excellence |
Germany |
University of Duisburg-Essen
Forsthausweg 2
47048 Duisburg Duisberg
Germany
Contact
Gudrun Bayer-Kulla
+49 (0) 2302 - 915131
e-Mail
External Links
Course
Office
Course Description
This course is part of the Master Program - Master of Science in Pharmaceutical Medicine - which can be single booked but also upgraded to a Certificate of Advanced Studies in Pharmaceutical Medicine or a Master Degree (Master of Science) in Pharmaceutical Medicine.
Learning Outcomes
After completion of this module the student will be able
· to compare and contrast the different challenges of healthcare expenditure presented in different economies
· to differentiate between rare and common diseases, and the barriers and opportunities for developing orphan drugs
· to value the role of patient groups in developing new products for rare diseases
· to classify the role of the agencies which police the economic viability of existing and new medical technologies
· to assess the multidisciplinary nature of pharmacoeconomics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century
· to analyze the impact on the various stakeholders, including regulators, pharmaceutical companies, healthcare professionals and patients
· to assess the fundamental concepts of health care financing and basic health economic principles
· to evaluate market access regulations and introduce market access strategies and policies
· to evaluate the scientific, socio-ethical, pricing and reimbursement problems related to developing and marketing orphan drugs
· to prepare the structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmacoeconomics and quality-of-life
· to organize the integration of health economics into pharmaceutical R&D process
· to analyze health economics and pricing decisions
· to assess current trends and new procedures/technologies in health economics in the USA, UK and Europe
· to analyze methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products
· to assess the role of pharmacoepidemiology in the life-cycle management of a medicine
· to analyze principles and practical application of health economics and patient-reported outcomes within the pharmaceutical industry
· to analyze the legal, economical and ethical considerations for health care spending and allocation decisions
· to manage the practical use of health economics and their influence of the health care Systems
· to plan quality of life assessments, cost minimisation analysis, cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis, QALYs
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Essen Germany
|
Essentials of EU Regulatory Intelligence Virtual Live Training Course
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
Ethical and Legal Aspects of Clinical Trials
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
41 61 267 19 52
e-Mail
External Links
Course
Office
Course Description
The implementation of clinical research projects requires conscientious review of research projects not only in terms of their scientific quality but also in regard to their ethical adequacy and appropriateness. How can we balance the risk-benefit of our projects Given the importance of ethics for the conduct of drug development and research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.Each of these aspects will be carefully considered and discussed in the context of international and national principles and guidelines. These issues need to be carefully adhered to strengthen the health of the clinical trial enterprise to the benefit of patients and the overall health of the public. During our course, representatives from different institutions will introduce and discuss the most important concepts, tools, principles, and methods that can be useful in approaching and resolving ethical dilemmas. Realworld examples and case studies will be introduced and discussed.
Learning Outcomes
By the end of the course, students will be able toName key principles of ethical considerations during clinical research and developmentDiscuss ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical trialsUnderstand international and national principles and guidelines which have to be followed when performing clinical trials
Language
English
Course Length
3 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
EU Regulations and Guidelines for Pharmacovigilance
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Course Description
Introduction
In 2007 pharmacovigilance regulations were brought together in an update of Volume 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use. It brings together guidance on the requirements, procedures, roles and activities of the various stakeholders on the collection, verification and presentation of adverse reaction reports in order to exchange information within the EU. Volume 9A also incorporates international agreements reached in this arena within the framework of the International Conference on Harmonisation (ICH). Thus it attempts to harmonise the disparate regulations and the practice of pharmacovigilance in the pharmaceutical industry and regulatory authorities. This course gives delegates a professional working knowledge of EU pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance.
Aims
- To explore the law and guidance defining EU Pharmacovigilance requirements and issues associated with their current interpretation
- To analyse the operational aspects of case processing, from receipt to electronic reporting, both for individual cases and the construction of aggregate reports such as Periodic Safety Update Reports (PSURs)
- To review critically, the qualitative aspects of the pharmacovigilance system such as quality assurance, audit, compliance, post-authorization safety studies signal detection, risk management and communication
- To explore critically, the role of the Qualified Person in Pharmacovigilance (QPPV)
- To analyse the impact of licensing agreements on pharmacovigilance
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completion of this course delegates should be able to:
- Analyse and explain the expectations and scope of the EU pharmacovigilance system
- Choose, justify and assemble the appropriate tools and manage the processes necessary to facilitate regulatory compliance
- Appraise the role and responsibilities of the QPPV
- Critically discuss the broad issues associated with licensing agreements
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
FOLLOW-ON DRUGS: GENERIC, BIOSIMILAR & NON-BIOLOGICAL
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Study Manager: Ms. Judit Lendvay, Mob: +36304757366; Email: cemdc3@gmail.com; Dr. Sandor Kerpel-Fronius, Course Director
_+36304757366
e-Mail
External Links
Course
Course Description
The lecturers will discuss the development, regulations, and marketing of various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products. It will be a unique experience to overview this very rapidly developing field and to understand how do these types of drugs modify the marketing policy of medicinal products.
Learning Outcomes
1. Compare the scientific and regulatory basis for the definitions of the various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products, define their significance in the life-cycle management of medicines.
2. Choose the right timing of pharmacokinetic studies during follow-on drug development.
3. Assess the appropriate in vitro and in vivo methods to establish equivalent bioavailability of generic drugs.
4. Analyze the diversity caused by the development of independent formulations for the same active ingredients by the follow-on producer.
5. Comprehend and appreciate the causes leading to the diversity of the biosimilar medicinal products manufactured by different producers.
6. Appreciate the complex non-clinical and clinical comparative study requirements needed to evaluate the biological and immunogenic properties of biosimilar medicinal products including biosimilar monoclonal antibodies
7. Appreciate the specific properties of different complex non-biological similar medicinal products
8. Analyze, comprehend and assess the complexity and international diversity of regulatory requirements for evaluating the efficacy and safety of follow-on non-biological similar products
9. Evaluate the public health significance of follow-on drugs on the market. Comprehend the differences in the pricing principles of follow-on generic, biosimilar and non-biological medicinal products
10. Assess the clinical pharmacological problems associated with reference pricing
11. Appraise the various clinical pharmacological issues related to the clinical interchangeability of generic, biosimilar and non-biological similar products drugs.
12. Appraise the international significance of quality assurance of follow-on products.
13. Assess the international medical significance of counterfeiting drug.
14. Appreciate the factors influencing the adoption of follow-on drugs in the everyday practice.
Scientific Areas
Pharmaceutical medicine. Medicines development, regulation and marketing of drugs.
Language
English
Course Length
4 days
Next Course Start Date
May 16-19, 2019
Scholarship available
No
Course Location
Budapest Hungary
|
Frontiers in Drug Development Seminar Series
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
41 61 267 19 52
e-Mail
External Links
Course
Office
Course Description
ECPM offers one day seminars on new trends and developments in drug development science. These seminars provide the opportunity to integrate work and further education, to discuss with experts face-to-face and to build an international network. The seminars are part of our ECPM Diploma Course modules that take place in February, June and September of each year.
Learning Outcomes
- Future trends in drug development including Future Information Technologies, Nano-Technologies, Computer Simulation and Modelling, Personalised Medicine, Genomics, Biologicals and Biosimilars, Advanced Therapeutics- Regulatory Agency updates from FDA, EMA and Swissmedic.- Ethical, Economic and Epidemiological Considerations and Concepts in Drug Development.
Language
English
Course Length
1 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Fundamentals in Health Economics
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
This course provides the participants with an understanding of the key principles and methodological concepts of health economics. The role of health-economic thinking in the drug development process is addressed. Two group exercises will complement lectures and discussions.
Learning Outcomes
- Understand the fundamental concepts of health economics.- Understand key principles of health economic evaluation.- Be able to assess and appraise a published health economic analysis according to guidelines and checklists.- Understand the importance of health economic/pharmacoeconomic methods and concepts for the drug development process, clinical trials, and post-marketing surveillance.- Understand how policy makers set priorities in health care and how health economic evaluations support this process- Understand the importance of health technology assessment in different health care systems.- Understand rational choice and priority setting using economic evaluation.
Language
English
Course Length
2 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Fundamentals of Quantitative Benefit-Risk Assessment Methods in Decision Making On Medicines
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives:
Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development. This module will address the decision-making on medicines by different stakeholders during the life cycle of a drug and how benefit-risk assessment tools may be applied in this process. Principles and fundamental methodologies for quantitative benefit/risk assessment, the strengths and weaknesses of these methodologies, and how to apply these methodologies in practice, will be discussed.
Topics covered:
Introduction to benefit-risk analysis methods
Benefit/Risk assessment during life cycle of medicines
Measures based on statistics/simulation
Health outcomes models
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Genomics in Drug Development
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
Genomics in Drug Development is a specific and debated approach tailored to the individual patientrsquos genome.Because of the high cost of failures, insights that increase the probability of success of bringing a drug program to approval are critical to boost the productivity and efficiency of drug development. It has been proposed that using germline human genetics to drive drug discovery can overcome some of these issues. Drug targets with underlying human genetic support linked to their indication are 2-fold more likely to gain approval in the United States and European Union as compared with drug targets without human genetic support.To get to the point where Using Genetics and Genomics in Drug Discovery, Drug Development and further in Clinical Development can be achieved, there have to be set and defined regulations and addressed different questions regarding Ethical, Legal and Social Aspects as well as Data Safety and Data Protection.
Learning Outcomes
By the end of the course, students will be able tounderstand Genetic Epidemiology and Public Health Geneticsknow how Genetics and Genomics are used for Target Identification, Drug Discovery, in Clinical Development and in the Treatment of Genetic Diseaseshave an overview of Genetics and Genomics in Drug Safety Evaluationsee the importance of Ethical, Legal and Social Aspects incl. Data Protection Aspectsnbsp
Language
English
Course Length
2 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Global Pharmacovigilance Regulatory Requirements: What's New?
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Office
Course Description
Programme features
- Compliance in the US - how to satisfy the FDA and the US 'Tome'
- Compliance in the EU - a regulator's perspective
- Volume 9A and the new EU Commission Pharmacovigilance package
- The QPPV in the EU
- Legal aspects
- The use of Electronic Data Standards in supporting compliance
- Compliance in licensing and due diligence
- Preparing for and surviving a compliance inspection
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completion of this course delegates should be able to:
- Critically review and interpret current rules and guidelines pertinent to ensuring compliance with relevant pharmacovigilance regulations
- Plan and prepare for pharmacovigilance regulatory inspections
- Optimise company procedures and processes subject to regulatory inspection
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
GVP-Auditor
|
FORUM Institut für Management GmbH
|
Centre of Excellence |
Germany |
FORUM Institut für Management GmbH
Vangerowstrasse 18
69115 Heidelberg
Germany
Contact
Dr. Henriette Wolf-Klein
49 (0)6221 500 680
e-Mail
External Links
Course
Office
Course Description
In unserem Lehrgang werden Sie umfassend auf eine gute GVP-Auditpraxis vorbereitet. Die Workshops an Seminartag 2 bieten Ihnen die Moeglichkeit, das Erlernte unmittelbar in der Praxis zu erproben. Was sind die Schluessel zu einem erfolgreichen Pharmakovigilanz-Audit, was gehoert in einen guten Auditplan, worauf muss beim Interview mit der QPPV geachtet werden, was ist beim Dokumentenreview zu beachten, was gehoert in einen Audit-Dienstleistungsvertrag, was sind die Erwartungen einer Inspektorin/eines Inspektors an die Planung, Durchfuehrung und Dokumentation eines Audits. Diese und viele weitere Fragen beantworten unsere qualifizierten Experinnen.
Learning Outcomes
Nach dem Seminar koennen Sie Pharmakovigilanz-Audits nach den neusten Regularien begleiten und durchfuehren, zielfuehrende und effektive Interviews fuehren, Auditplaene erstellen, Pharmakovigilanz-Vertraege und wichtige Pharmakovigilanz-Dokumente detailliert verstehen, Audits richtig outsourcen, risikobasierte Auditstrategien erstellen, vorhandene Ressourcen fuer Audits richtig einsetzen und kritische Auditsituationen professionell meistern.
Scientific Areas
Dieser Online-Lehrgang richtet sich an Fach- und Fuehrungskraefte der pharmazeutischen Industrie, die die Funktion des GVP-Auditors anstreben oder bereits erworben haben und in Zukunft Pharmakovigilanz-Audits eigenverantwortlich und sicher planen und durchfuehren moechten. Pharmakovigilanz-Kenntnisse werden fuer diesen Lehrgang vorausgesetzt.
Language
German
Course Length
2 Day(s)
Next Course Start Date
Contact course provider
Scholarship available
No
Course Location
Online Germany
|
Healthcare Market Place
|
Kings College London
|
Centre of Excellence |
United Kingdom |
Kings College London
Kings Building,
Wc2r 2ls London
United Kingdom
Contact
Programme Officer
+44 (0)20 7848 4684
e-Mail
External Links
Course
Fees
Office
Course Description
This module explores all aspects of the marketing of medicines. We will consider market analysis and planning, advertising and codes of practice. There will also be sessions on health technology assessment and an introduction to pharmacoeconomics.
Teaching will be supplemented with case studies and practical exercises.
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
How to Prepare for Pharmacovigilance Audits and Inspections
|
Drug Information Association
|
PharmaTrain Centre |
Germany |
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
Gunta Sveke
e-Mail
External Links
Course
Course Description
Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.
Learning Outcomes
At the conclusion of this course, participants should be able to: - Participate in audits / inspections and mock audits / inspections - Assess how to handle the actual audit / inspection and responses to requests and findings based on the understanding of audit / inspection methodology the legal basis of inspections or the contractual basis of audits and the appreciation of regional differences - Prepare responses to audit / inspection findings, including responses and corrective/ preventive action (CAPA) plans - Prepare their function for an audit / inspection: roadmap, teams, tasks, and documents - Assess regional differences with respect to European and US FDA inspections
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Berlin Germany
|
Identifying Susceptibility for Adverse Drug Reactions
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
contact@eu2p.org
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To understand effect modification
To understand the principles of genetic susceptibility for drug risks
Topics covered:
Introduction, risk factors and effect modification
Variability in drug response and principles of pharmacogenetics/pharmacogenomics
Assessment of pharmacogenetic influence through candidate genes and genome-wide association studies (GWAS)
Ongoing initiatives and biological interpretation
Successes and failures in pharmacogenetic studies
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Information and Communication About Benefit-Risk of Medicines (Basic Principles)
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives
To identify the key roles, routes and tools of communication on medicines and their risks
To know the evolution of medicines risk communication and overview of the regulatory responsibilities and requirement
To be aware of environmental drug impact communication
Topics covered:
Principal actors in communication on medicines risk, of traditional and new forms of communication, of routes of communication and their evolution through time
Basis of risk communication process
Regulatory Responsibilities and Requirements Concerning Medicines Risk Communication
Communication of actual and alleged risks associated to medicines: three different scenarios
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Introduction to Benefit-Risk Assessment and Pharmacoeconomics Communication in Decision Making
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
The objective of the module is to gain insight in the role of benefit-risk assessment and pharmacoeconomics in the process of decision-making on medicines by different stakeholders.
Topics covered:
Introduction
Benefits
Risk/Harms
Principles and methods of comparative benefit-risk assessment
Principles of Pharmacoeconomics
Learning Outcomes
At the end of this module, trainees will be able to:
- Delineate the process of decision-making and the perspectives of the stakeholders involved
- Explain the rationale of benefit-risk assessment and pharmacoeconomic evaluation
- Evaluate the methodology and results of benefit-risk and pharmaco-economic studies
- Translate of the results into the process of decision-making
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Introduction to Pharmacoepidemiology
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
Pharmacoepidemiology is a key discipline for understanding the safety of medicines. It is also being increasingly recognised as a practical tool for supporting risk management and in planning safety activities at the time medicines are authorised. This course is aimed at introducing delegates to the core concepts of this scientific discipline. Attendance at this course can be used as part of the training required for Higher Medical Training (HMT) and Pharmaceutical Medicine Specialty Training (PMST).
Aims
- To provide students with a grounding in, and analysis of, core principles of epidemiology
- To show how epidemiological techniques are applied to pharmacoepidemiological studies
- To review the development of pharmacoepidemiology as a science and its place in modern medicine
- To review modern methods and data sources used in pharmacoepidemiology
- To develop a critical understanding of the types, assessment and appropriate application of post-marketing drug safety data and their contribution to the marketing, regulatory compliance, safety monitoring and risk management associated with pharmaceuticals
This course can be taken as a stand alone short course or as part of our postgraduate programme in pharmacovigilance, in association with the University of Portsmouth.
Learning Outcomes
On successful completion of this course delegates should be able to:
- Critically analyse the relationship between epidemiology and pharmacoepidemiology
- Define and justify the elements of an ideal database to be used to conduct a pharmacoepidemiological study of a drug safety issue
- Differentiate the important features of pharmacoepidemiological investigations that allow comparisons within and between pharmacoepidemiological data resources
- Critically apply common techniques of analysis in the interpretation of pharmacoepidemiological data for pharmacovigilance purposes
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Southampton United Kingdom
|
Introductory course in exploratory medicines development, Parts I and II
|
Association for Applied Human Pharmacology (AGAH)
|
PharmaTrain Course |
|
Association for Applied Human Pharmacology (AGAH)
Goernestraße 30
D-20249 Hamburg
Germany
Contact
External Links
|
Key Roles and Stakeholders in Medicines Risk Communication: Duties and Challenges
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
This module will address in more depth the challenges (rationale , emotional and logistical) of Risk communication that have been raised in previous modules
Objectives
To consider the evolution and social impact of the concept of risk and benefit risk
To explore the understanding of risk perception and uncertainty
To consider challenges in healthcare providers-patients communication
To know the regulatory agencies strategies to address the challenges of risk communication
Topics covered:
Historical perspective. Evolution of concept of risk communication. Social impact of drug risk communication
Risk perception. Actual vs perceived and factors influencing perception. Population vs individual risk perception
Concept of uncertainty. How to deal with this in risk communication
Nature and importance of communication of risk of medicines: accessibility of data, conflict of interest and independent information
Regulatory agencies' strategies to address the challenges of risk communication
Language
(Afan)/Oromoor/Oriya
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Life Science Leadership and Business Strategies
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
This course offers the basic principles of innovation leadership and gives insight the theory and practice of what it takes to be an effective leader. Participants will get the core management skills they need for fully leverage the human capital of their own project or company. The course aims to fill the gaps between leadership and management, vision and reality, strategy design and implementation in the Life Sciences, Health, or Insurance Industries. It includes Product Lifecycle in the Life Sciences Industry Financial Management Leadership motivating global teams and social competence Business Development marketing, pricing Intellectual Property, Licensing Communication and Change Management Legal and Social Responsibility CEO role model. The course program covers four days (two blocks with each two days) including presentations, company and industry relevant interactive teaching with case studies, practical exercises and short communication by participants.
Learning Outcomes
Understand basic principles of innovation leadership for profitable growth and results Describe new tools and practices in bringing a new molecule to market Be capable to utilise basics of legal and health economics including constraints of conducting a successful biopharmaceutical business Recognise evolving expectations from the regulatory and financial environment Outline the basics in various types of alliances, valuation of technologies, portfolio management, joint ventures, partnerships, pricing of drugs Understand structuring successful collaborative arrangements between pharmaceutical companies, SMEs and universities Appraise the role and key competences and tasks of a CEO, including perspectives of an employee, a CEO and a board member.
Language
English
Course Length
4 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Medical Aspects of Adverse Drug Reactions
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
Adverse Drug Reactions (ADRs) are a major clinical problem. An understanding of the clinical aspects of ADRs is a fundamental requirement for any professional in the field of pharmacovigilance. This course covers recognition and interpretation of ADRs and their underlying toxopathology and pharmacology. A panel of outstanding multi-disciplinary tutors will provide a comprehensive and up-to-date understanding of all aspects of ADRs through this interactive lecture-based course.
Aims
- To provide delegates with a grounding in and analysis of, the core principles of medical diagnosis including pattern recognition, and therapeutics
- To analyse some of the core concepts of clinical pharmacology relevant to the conduct and interpretation of pharmacoepidemiological research
- To review the mechanisms of drug action, the concept of drug potency, the role of pharmacodynamics and pharmacokinetics (including genetic and immunological factors) in determining variability in drug response and drug interactions
- To review the classification of ADRs and pathophysiology according to body system and associated public health burden
Programme features
- Principles of medical diagnosis
- Comprehensive and up-to-date understanding of medical and scientific aspects of ADRs
- ADR examples
- Overview of ADRs and interactions
- Genetic and metabolic basis of ADRs
- Immunological aspects of ADRs
- ADRs by system organ class
- Regulatory aspects including guidelines and causality assessment
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On completion of this course delegates should be able to:
- Analyse the complexity of undertaking medical diagnoses and the influence of human behaviour (prescriber and patient) and drug factors important in therapeutic decision making
- Critically examine the important features associated with Type A and Type B reactions and identify factors associated with individual susceptibility
- Appraise the rationale for performing clinical investigations and the importance of correct interpretation of results
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Methods in Clinical Research, Pharmacoepidemiology and in the Assessment of the Efficacy of Medicines
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To develop a robust knowledge and familiarity with the methods used in clinical research and pharmacoepidemiology to evaluate the efficacy and effectiveness of medicines and therapeutic interventions.
To develop a robust knowledge and familiarity with the methods used in randomised clinical trials.
To analyse and discuss ethical and legal issues in clinical research and randomised clinical trials.
To understand principles of synthesizing scientific data through systematic review and meta-analysis of clinical trials.
To acquire a specialised and robust knowledge of specialized requisites in the design and interpretation of clinical trials in specific areas
Topics covered:
Scientific methods and causality.
Statistical and methodological issues for the design and analysis of clinical trials.
Ethical issues in the development of clinical research and clinical trials.
Systematic review and meta-analysis of randomised clinical trials.
Other methods for the evaluation of the effectiveness of medicines and therapeutic interventions.
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Module 1 Drug development with a focus on the changing health care environment
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
1.1 Setting the scene the context of drug development1.2nbspIntegrated product development from discovery phase to market authorization1.3nbspDrug screening from animals to recombinant proteins and translational research1.3.1 Testing in animals current use, ethical and regulatory aspects, limits and alternative approachs1.3.2 High Troughput Screening setting-up of new functional assays, robustness, troughput and quality of assays1.3.3 Systems biology and translational research1.4 Big Data and personnalized medecine How AI can potentially reinvent the drug design and development 1.4.1 Concept of personnalized medicine1.4.2 AI for Clinical Trial Design1.4.3 Big Data, Robots and AI in Medecine and Healthcare
Learning Outcomes
At the end of this module, studentsnbspshouldnbspbe able to describenbsp1- The main steps in drug developmentnbsp2- Particularities of the evolving healthcare environmentnbsptoday3- The Main steps and innovation in drug screeningnbsp4- Principles of translational research and personalized medicinenbsp5- How Artificial Intelligence can play a role in drug design and developmentnbsp
Language
English
Course Length
8 online sessions
Next Course Start Date
January 2025
Scholarship available
No
Course Location
online Belgium
|
Module 1a (Int): Introductory Programme, Module 1b: Principles of Discovery of Medicines and Development Planning
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judit Lendvay
e-Mail
External Links
Course
Fees
Office
Course Description
INTRODUCTORY MODULE - under discussion
The introductory module section provides an introductory overview of medicine development in general and its place in healthcare
PRINCIPLES OF DISCOVERY OF MEDICINE AND DEVELOPMENT PLANING
Module Leaders: P. Arányi, Hungary and M. Gottwald, Germany
The general introductory section is followed by the detailed discussion of the drug discovery process.
Learning Outcomes
INTRODUCTORY PROGRAMME
Process of drug development and identity of critical factors and decision points
Importance of the patient in drug development
Background to the development of the regulation of medicines and the role of the competent authorities
Monitoring of drug safety
PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING
Principles and practice of medical marketing
Role of pathophysiology and molecular biology-based pharmacology in drug development
Principal steps in discovering, modifying, assessing and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication
Resource planning (in terms of project management, budgeting and cost-control) involved in the management of a drug development programme
Principles of translational research and its role in drug development
Functions and elements (including business aspects) involved in the integrated development of a new drug
Scientific Areas
- PK/PD modelling
- Stem cells and regenerative medicine
- Target discovery and lead selection
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Budapest Hungary
|
Module 2 From pre-clinical to First-in-Human studies
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
2.1 Pre-clinical strategy and study designnbsp2.1.1 Non clinical safety strategies- GLP and pre-clinical testing requirements- Stages of development and registrationnbsp- Study protocol designnbsp- Pre-clinical strategy time and cost analysis- Special population requirements and regulatory compliancenbsp2.2 Pre-clinical safety principles of pharmacology and toxicology2.2.1 Non-clinical testing of chemical and biological compounds, including pharmacology (ADME)2.2.2 The right dose for first-in-human administration2.2.3 Toxicology testing (Part I)2.2.4 Toxicology testing (Part II)2.2.5 Genetic and genomic factors in drug development and drug response2.2.6 Novel approaches in investigative toxicologynbsp2.2.7 Computational toxicology methods for prediction of Preclinical Safety Endpointsnbsp2.3 Drug formulation2.3.1 Main aspects of drug formulation, Concept of drug bioavailability2.3.2 Non-conventional dosage forms, Nanotechnologies for drug delivery2.4 Manufacturing 2.4.1 Technical pharmaceutical development formulations, primary packaging, delivery systems, Quality Management System, Quality by Design, and Process Analytical Technologies2.4.2 GMPs and the department/system structures necessary for development and manufacturing, EMA and FDA agencies and inspections2.5 Moving to first-in-human studies2.5.1 Ethics in the pharmaceutical industry2.5.2 Requirements, ethics and regulations for first-in-human studies2.5.3 Accelerating the move to clinical trials (possibilities and opportunities with computer assisted modelling on the way to proof of concept)2.5.4 Strategic importance and practical organization of Phase I studies (responsibilities, planning and activities)
Learning Outcomes
At the end of this module, students should be able to describenbsp1-nbspThe principles of pre-clinical strategynbsp2- Requirements, ethics and regulations for pre-clinical and first-in-human studiesnbsp3- Basic concepts of pre-clinical pharmacology and toxicologynbsp4- The main aspects of drug formulation and innovation in this field5- Technical pharmaceutical developmentnbsp6- Requirements and regulations in drug manufacturingnbsp7- Planning and practical organization of Phase I studiesnbsp
Language
English
Course Length
16 online sessions
Next Course Start Date
09/03/2023
Scholarship available
No
Course Location
online Belgium
|
Module 2: Non-Clinical Testing, Pharmaceutical and Early Clinical Development
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Slovenia |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judith Lendvay
+36304757366
e-Mail
External Links
Course
Fees
Office
Course Description
Module Leaders: I. Mlinaric-Rascan, University of Ljubljana, Slovenia and Beatriz Silva Lima, University of Lisbon, Portugal
Cooperative European Medicine Development Course (CEMDC)
Base Course. Module 2.
Date: under discussion
Place Ljubljana, Slovenia
Learning Outcomes
Choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds
Integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials)
Steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds)
Planning of clinical trial supplies for test substance and comparators (active and placebo)
Overview of non-study requirements prior to First-into-Man studies
Molecular and cellular basis of toxic reactions
Principles and practical application of pharmacokinetics and toxicokinetics
Early exploratory development in man
Principles of clinical pharmacology and their application to clinical development
Influence of genetic factors in drug development and drug response
Scientific Areas
+ PK/PD modelling
- Target discovery and lead selection
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Ljubljana or Budapest, Slovenia Slovenia
|
Module 3 Clinical studies Planning, managing and collecting data
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
3.1 Early studies in patients3.1.1 Pharmacokinetics basic concepts and applications3.1.2 Drug metabolism drug-drug interaction studies3.1.3 Special PK topics3.2 Clinical trial design3.2.1 Different types of clinical trials study designs3.2.2 Randomisation modes3.2.3 Statistical considerations in planning clinical trials (choice of endpoints, hypothesis, Alpha and Beta risks, sample size calculation)3.2.4 Innovative study designs3.3 Planning and managing clinical trials3.3.1 GCP requirements and regulatory aspects3.3.2 Confirmatory Clinical Development Plan and Target Product Profile (TTP)3.3.3 Setting up a clinical trials (Part I)3.3.4 Setting up a clinical trial (Part II)3.3.5 Monitoring safety in clinical trials and drug development3.3.6 Developing Risk Management Plans ndash challenges amp Risk-based and remote monitoring in clinical trials3.3.7 Patient-centric approach in clinical research Ethics, involvement and collaboration3.3.8 Outsourcing clinical trials and managing contracts3.3.9 Audits in clinical trials key features of audits and inspections, the keys to preparing for and effectively managing inspections, roles and expectations of key personnel, differences between inspections by different authorities3.4 Gathering data from clinical trials3.4.1 Clinical trial data collection and management3.4.2 Patient adherence and persistence in trials (uptake ofnbspmobile health,nbspe-tools,nbspbig data analysisnbspand personalized medicine)nbsp3.5 Blockchain in Clinical trialsnbspScience-fiction or science-fact nbspThe case for blockchain applications in clinical trialsnbspBarriers and challenges yet to be overcomenbsp
Learning Outcomes
At the end of this module, studentsnbspshouldnbspbe able to describenbsp1- The main aspects of early studies in patients, and their impact on the drug development plannbsp2- The design of various types of clinical studies, along with the statistical aspects of these designsnbsp3- Key issues involved in conducting a clinical study in line with Good Clinical Practice (GCP)nbsp4- The main safety issues in clinical trials and drug developmentnbsp5- Data collectionnbspprinciples and tools6- Key steps and methods in data managementnbsp7- Blockchain applications in clinical trialsnbsp
Language
English
Course Length
20 online sessions
Next Course Start Date
12/09/2023
Scholarship available
No
Course Location
online Belgium
|
Module 3: Clinical Development of Medicines: Exploratory and Confirmatory
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judith Lendvay
+36304757366
e-Mail
External Links
Course
Fees
Office
Course Description
Module Leaders: R. Maciulaitis, Lithuania and D. Niese, Germany - under discussion
In this module the early clinical development of medicines from non-clinical to phase II clinical evaluation will be reviewed. The definition and the functional significance of the Proof of Concept in medicnes development will be discussed in detail.
Learning Outcomes
Early studies in patients: dose-finding / proof of concept studies and their impact on drug development plan
Clinical trial design (including legal, regulatory, ethical and practical aspects): international differences
Principles and application of statistics in clinical trials
Procedures for clinical trial data collection (paper and electronic) and data management (including validation processes) to ensure optimal quality data
Key strategic issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP)
The role of the investigator drug brochure (IDB)
Principles and practical relevance of ethical issues in biomedical research.8. Legal and ethical provisions for protection of clinical trial subjects
Scientific Areas
PK/PD modelling
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Budapest Hungary
|
Module 4 Data Evaluation and Biostatistics
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
4.1 Clinical trial protocols and Investigator Drug Brochure (IDB) 4.1.1 Clinical trial protocol a key document amp Reading and understanding clinical trial protocols amp Role of the Investigator Drug Brochure (IDB)4.1.2 Regulatory codes and guidance for authoring the IDB4.2 Biostatistics evaluating clinical data4.2.1 Statistical methods in clinical research (I) Probability distributions and descriptive statistics4.2.2 Statistical methods in clinical research (II) Statistical models4.2.3 Statistical methods in clinical research (III) Inferential statistics4.2.4 Statistical methods in clinical research (IV) Epidemiological methods4.2.5 Statistical methods in clinical research (VI) Principles of machine learningnbsp nbsp4.3 Evaluating safety data4.3.1 Methods for the evaluation of safety data in clinical trials4.3.2 Background and implementation of Development Safety Update Reports (DSUR) amp Data Safety Monitoring Boardsnbsp4.4 Data interpretation and scientific writing4.4.1 Different aspects of clinical study reports data and conclusions in writing amp Preparing review documents for regulatory submissions amp Writing a paper for publication4.4.2 Submitting to peer-reviewed journal, handling the reviewerrsquos comments
Learning Outcomes
At the end of this module, studentsnbspshouldnbspbe able to describenbsp1-nbspDevelopmentnbspof a clinical trial protocol and the role of the Investigator Drug Brochure (IDB)nbsp2- How to evaluate and interpret clinical trial results in scientific papers3- The main statistical methods used in clinical data analysis, and the current challenges around the p-valuenbsp4- The main aspects of clinical study reports, and documents for regulatory submissionnbsp
Language
English
Course Length
11 online sessions
Next Course Start Date
11/01/2024
Scholarship available
No
Course Location
online Belgium
|
Module 4: Clinical Trials
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judith Lendvay
+36304757366
e-Mail
External Links
Course
Fees
Office
Course Description
Module Leaders: Anthony Fox, UK and Katalin Mazalin, Hungary - under discussion
The science. methodology and ethics of large, multicenter clinical trials will be reviewed. Specific attention will be given to clinical trials in specific populations: pediatric, elderly subjects as well as patients suffering from rare diseases. Study types, statistical aspects, side effect reporting, the definition of target product profile will be discussed.
Learning Outcomes
Various types of clinical studies and the methods used to choose the appropriate design
Main statistical methods used in clinical research
Key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution
Collection, evaluation and reporting of adverse event data in clinical trials
Various quality management issues in clinical trials
Impact of emerging results on the drug development plan
Key operational and strategic issues in the clinical development plan
Evaluation of the outcome of drug development: final therapeutic profile / usage of a medicine. Evidence Based Medicine
Role of the Target Product Profile (TPP) and Target Product Claims (TPC)
Role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees
Statistical issues in statistical report writing
Evaluation and interpretation of clinical trial results
Principles and practical application of critical appraisal
Scientific Areas
PK/PD modelling
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Budapest Hungary
|
Module 5 Registration and pharmacovigilance
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
5.1 Drug Registration5.1.1 European procedures and the international environment (I)5.1.2 European procedures and the international environment (II)5.1.3 Preparation of a new drug application - The Common Technical Document (CTD) format5.1.4 Special issues orphan products5.1.5 Understanding shortcomings in the application, and improving chances of approval5.2 Pharmacovigilance amp medical information5.2.1 Back to basics in pharmacovigilance5.2.3 EU regulations and guidelines in pharmacovigilance5.2.3 Everyday pharmacovigilance5.2.4 Overview of Patient Support Programs (PSPS) - Recent trends in Pharmacovigilance5.2.5 Medical information communicating with healthcare practitioners amp Summary of product characteristics and user package leafletnbsp5.3 Pharmacoepidemiology5.3.1 Principles of pharmacoepidemiology5.3.2 Study methods and data resources5.3.3 Interpreting pharmacoepidemiological datanbsp amp Role of pharmacoepidemiology in a medicinal productrsquos lifecycle
Learning Outcomes
At the end of this module, studentnbspshouldnbspbe able to describenbsp1-General principles of medicine regulation (pre- and post- approval)nbsp2- Principles of pharmacovigilance and medical information3- The role of pharmacoepidemiology in a medicinal productrsquos lifecycle
Language
English
Course Length
13 online sessions
Next Course Start Date
09/04/2024
Scholarship available
No
Course Location
online Belgium
|
Module 5: Regulatory Affairs; Drug Safety & Pharmacovigilance
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judith Lendvay
+36304757366
e-Mail
External Links
Course
Fees
Office
Course Description
Module Leaders of the regulatory section: J. Klimas, Slovakia and A. Irs, Estonia - under discussion
In the module regulatory aspects of medicines development and application through the entire life cycle of medicines will be highlighted
Module Leaders of the Pharmacovigilance section: Z. Guney, Turkey and L. Stankovics, Hungary
In the pharmacovigilance section of this module the process of side effect reporting will be described. In addition to the clinical pharmacologic evaluation of adverse events, the industrial and international regulatory management of reported events will be described in the frame of the pharmacovigilance organisation. Finally the concept risk management will be reviewed.
Learning Outcomes
General principles of medicines regulation (both pre- and post-approval) at EU and global level
Impact of medicines legislative requirements on regulatory activities within a pharmaceutical company
Role of national agencies and international bodies in medicines regulation
National provisions for management of (1) off-label / unlicensed use of medicines (2) controlled drugs
Place of International Conference on Harmonisation (ICH) in medicines regulation (including Common Technical Document [CTD])
Regulatory processes in the EU / EEA areas
Regulation and legal considerations of Product Information
Principles and practical application of medical devices regulation
Roles of the various stakeholders (including pharmaceutical and other healthcare professionals, investigators, regulatory authorities) in drug safety and pharmacovigilance
Classification of adverse events / adverse drug reactions
Safety reporting requirements (according to the type of adverse event / reaction) pre- and post-approval
Ongoing management of drug safety issues pre- and post-approval (including Risk Management Plans [RMPs], Periodic Safety Update Reports [PSURs]); ongoing benefit / risk assessment throughout the life-cycle of a medicine
Role of pharmacoepidemiology in the life-cycle management of a medicine
Factors influencing medication safety from the perspective of each stakeholder
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Budapest Hungary
|
Module 6 Health Economic and Biopharmaceutical market
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Course Description
6.1 Principles and practical applications of health Economics6.1.1 Health economics assessment of medicinal products study quality concept and methods used to assess quality amp Health technology assessment6.1.2 Interpreting cost-effectiveness ndash Patient reported outcomes amp How the economic assessment affects market access6.1.3 Pricing and social security coverage of medicinal products (overview, issues and challenges in EU)6.1.4 Real world data and real world evidence6.2 Market access 6.2.1 Ethical and legal aspects6.2.2 Macroeconomic aspects6.2.3 Regulatory environment and market access in emerging markets6.2.4 Pharmaceutical marketing (I)6.2.5nbspPharmaceutical marketing (I)6.3 Innovation and improvement of health care6.3.1 Which new products are truly innovative6.3.2 Health databases for innovation and improving health care
Learning Outcomes
At the end of this module, students should be able to describe1- The principles in, and practical applications of, health economics and Health Technology Assessment within the healthcare marketplace2- The ethical and legal aspects of bringing a drug to market3- What makes a truly innovative productnbsp
Language
English
Course Length
11 online sessions
Next Course Start Date
10/09/2024
Scholarship available
No
Course Location
online Belgium
|
Module 6: Healthcare Marketplace; Economics of Healthcare
|
CEMDC, Semmelweis University
|
Centre of Excellence |
Hungary |
CEMDC, Semmelweis University
Nagyvarad ter 4
H-1089 Budapest
Hungary
Contact
Judith Lendvay
+36304757366
e-Mail
External Links
Course
Office
Course Description
Module Leaders: Z. Kaló, Hungary and D. Dubois, Belgium - under discussion
Pharmacoeconomic principles, their application in medicine development and marketing will be discussed. The healthcare market place, the principles and practice of drug marketing will be described. Finally the roles of Health Technology Assessment, patient organisations and methods used for pricing and reimbursement decisions, drug budget management will reviewed.
Learning Outcomes
At the end of this Module the student should be able to demonstrate an understanding of:
Life-cycle activities (clinical, regulatory and marketing).
Processes of production and review of product information to ensure adherence to ethical and legal principles pertaining to marketing activities (Good Promotional Practice).
Role of patient organisations.
Principles and practical application of health economics and patient-reported outcomes within the pharmaceutical industry.
Principles of health technology assessment (HTA) and its role in the supply of medicines to the marketplace.
Principles and practice of marketing within the pharmaceutical industry.
Drug budget control; pricing mechanisms.
Explain the multidisciplinary nature of pharmacoeconomics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century.
(ELM) Use in an appropriate manner the fundamental scientific theories underlying the application of health economic techniques to a range of healthcare interventions.
(ELM) Recognise and be capable of utilising basic relationships and techniques of healthcare management to maximise benefits from a given resource.
(ELM) Explain and present information associated with economic appraisal and assessment of new medicines carried out by NICE or similar agencies.
(ELM) Explain the role of the agencies which police the economic viability of existing and new medical technologies.
(ELM) Compare and contrast the different challenges of healthcare expenditure presented in different economies.
(ELM) Outline the structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmacoeconomics and quality-of-life, and be capable of explaining its evolution, strengths and weaknesses.
(ELM) Explain methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products.
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Budapest Hungary
|
Module 7a Particularities in the clinical development of Biologics
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Language
English
Course Length
2 online sessions
Next Course Start Date
TBD
Scholarship available
No
Course Location
online Belgium
|
Module 7b Medical devices an overview from manufacturer to patient
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Scientific Areas
- PK/PD modelling
Language
English
Course Length
2 online sessions
Next Course Start Date
TBD
Scholarship available
No
Course Location
online Belgium
|
Module 7d Challenges in Vaccine development from preclinical to clinical studies
|
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
|
Centre of Excellence |
Belgium |
Free University of Brussels (ULB), ULB-HeLSci, PHARMED
ULB-HeLSci
1070 Brussels
Belgium
Contact
Marie Lebacq
e-Mail
External Links
Course
Fees
Office
Language
English
Course Length
2 online sessions
Next Course Start Date
TBD
Scholarship available
No
Course Location
online Belgium
|
Monitoring Safety in Clinical Trials and Drug Development
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
The implementation of the Clinical Trials Directive was a critical event for clinical research and pharmacovigilance, which impacted on all those working in this area. Its standards have influenced regulatory expectations, together with new ICH standards such as the Development Safety Update Report and Pharmacovigilance planning, bringing new challenges to safety personnel. This course is aimed at providing delegates with an overview of some of the challenges companies faced in implementation of safety standards and best practice in managing their implementation in order to comply with applicable legislation and guidance.
Aims
- To provide delegates with a theoretical and practical understanding of the issues involved in pharmacovigilance planning and monitoring throughout drug development programmes
- To analyse the principals of risk management and illustrate their application to pharmacovigilance, including the role and application of Data Safety Monitoring Boards
- To review critically pharmacovigilance regulatory requirements plus corresponding roles and responsibilities of the pharmaceutical industry in safety data management for optimal protection of patients in clinical trials
Programme features
- Pharmacovigilance planning and monitoring in drug development, including communication to trial subjects
- Development of labelling - the developmental safety information through the core data sheet and SPC
- Risk management in drug development - planning and risk minimisation
- Monitoring safety in clinical trials
- Data Safety Monitoring Boards
- Clinical Trials Directive - current requirements, challenges and future changes
- Planning for the Developmental Safety Update Report
- Reporting to Eudravigilance Clinical Trial Module - practicalities and challenges
- Future drug safety regulatory challenges on the horizon for clinical trials and drug development
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completion of this course delegates should be able to:
- Demonstrate an informed critical awareness of regulatory safety requirements as they pertain to clinical studies
- Understand the role and situations where a study may deploy the use of Data Safety Monitoring Boards
- Identify and locate the key sources of information and documentation relevant to developmental risk management activities
- Critically explain the strengths and weakness of pharmacovigilance planning systems
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Periodic Safety Reports PSURs/ PBRERs
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a medicinal product to competent authorities at defined time points, post-authorisation. These reports are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the marketing authorisation and product information. PSURs must be submitted for all registered products regardless of marketing status. This course provides delegates with a working knowledge of the International Conference on Harmonisation (ICH) E2C guidelines for purposes of planning, writing and reviewing PSURs. Group sessions and workshops are included to address practical issues and application of the guidelines.
Aims
- To analyse the ICH E2C guidelines for writing PSURs
- To critically appraise the operational aspects of the planning, construction and frequency of submission of PSURs
- To explore the application of the guidelines to reporting safety data
- To critically review the key sources of adverse reaction case information
- This course is part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completetion of this course delegates should be able to:
- Analyse the purpose and scope of PSURs and MA holder responsibilities
- Assemble and appraise a PSUR from diverse information sources and explain the management steps in report submission
- Critically evaluate data within PSURs for purposes of signal detection
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Fareham United Kingdom
|
Personalized Health Care E-Learning
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Afghanistan |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Office
Course Description
This e-learning course provides an understanding of the key principles and methodological concepts of personalized drug development. The role of individualized treatment strategies is addressed, including all relevant clinical, ethical and governmental aspects.
Learning Outcomes
At the end of the course, the participants should be able toUnderstand the biological and clinical concepts of personalized medicineUnderstand the benefits and pitfalls of individualized therapies for patientsComprehend the basic elements of predictive and prognostic interventionsUnderstand the role of surrogate endpoints and clinically validated biomarkers in personalized medicineUnderstand pharmacogenetic and pharmacogenomic implicationsBe aware of the strategies of RampD processes with personalized drugsUnderstand the economics challenges of personalized medicine and how policymakers set priorities in individualized health careDetermine legal, regulatory and ethical aspects of personalised medicinenbsp
Language
English
Course Length
1 Hour(s)
Next Course Start Date
anytime
Scholarship available
No
Course Location
Afghanistan
|
Pharmacovigilance in Products Subject to Licensing Agreements
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
At a time when company strategies increasingly look to strengthen their portfolios through in-licensing, co-development, co-marketing or co-promotion opportunities this course aims to help pharmacovigilance professionals understand the impact of such arrangements on pharmacovigilance activities. The course covers the nature and types of relationships where agreements may be required, the approaches required for different types of relationship and what such agreements should contain. The course will be a balanced mix of presentations and workshops facilitated by people with experience in these areas. You will benefit from inter-professional learning with safety, regulatory and legal colleagues, sharing your experiences and comparing your strategies in this challenging area.
Outline:
- Nature and type of relationships
- Due diligence activities
- Content of safety agreements
- Challenges with International Sales Teams
- Perspectives from a small Pharmaceutical Company
- Managing relationships
- Legal aspects
- Compliance and audit
- Regulatory expectations – an inspector’s perspective
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
- Describe some types of agreements and relationships and consider the strengths and weaknesses of such approaches in the context of a safety agreements
- Demonstrate a critical awareness of modules for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
London United Kingdom
|
Pharmacovigilance Planning and Risk Management
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
A pro-active approach to risk management of drug safety is vital throughout the whole life-cycle of a medicinal product. The aim of this course is to critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product. The relationships between pharmacovigilance plans, risk management, pharmacoepidemiology and risk minimisation programmes will be the central theme. Experts will share their personal experiences in managing the risk of bringing new medicines to market, and outline new approaches to mitigating risk and improving decision making. Group interactive sessions will analyse recent 'real-world' challenges faced by marketing authorisation holders and regulators.
Aims
- To critically appraise the elements of a Risk Management System through evaluation of the relationship between pharmacovigilance and risk management plans
- To prepare for construction of Safety Specification and Risk Management Plans through critical evaluation of the latest concepts in tools and strategies for risk assessment and prevention
- To critically examine current recommendations and practices of managing risk and analyse the implications for decision-making
Programme features:
- Current regulation and guidance relevant to global risk management
- Safety specification and pharmacovigilance planning
- Risk management activities and the drug development programme
- Stakeholder perspectives on construction and execution of risk management plans
- Workshop to analyse recent challenges in the implementation of risk management plans
- Development of best practice techniques
- Management of drug safety after reclassification
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On successful completion of this course delegates should be able to:
- Critically interpret the purposes of risk management systems in drug safety and the challenges that risk management represents
- Plan, prepare and justify Safety Specification and Risk Management Plans
- Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Southampton United Kingdom
|
Pharmacovigilance Regulations
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To enable trainees to develop an understanding of European, USA and major local and worldwide regulations and guidelines concerning pharmacovigilance. Emphasis will be placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.
Topics covered:
Pharmacovigilance regulations: concept
The working Pharmacovigilance regulations.
Other related Pharmacovigilance regulations and guidelines.
Non-European pharmacovigilance regulations
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Pharmacovigilance Regulatory Processes
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To enable participants (specialists) to develop an understanding of the requirements of the Pharmaceutical Industry’s operational aspects of pharmacovigilance as it relates to the preparation and assessment of documents legally required by regulatory bodies. Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.
Topics covered:
Case reporting
Periodic reporting
Product Labelling and Risk Management Plans
Contractual arrangements
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Post Graduate Diploma in Pharmaceutical Medicine
|
Stellenbosch University
|
Centre of Excellence |
South Africa |
Stellenbosch University
PO Box 19063;
7505 Cape Town
South Africa
Contact
Bernd Rosenkranz
e-Mail
External Links
Course Description
This 2-year, part-time course (starting January each year) is a joint venture between the Division of Pharmacology, Department of Medicine at the Stellenbosch University Faculty of Health Sciences and the Tiervlei Trial Centre. It aims to equip students with a thorough understanding and knowledge of new drug development and the principles of clinical pharmacology; pharmaceutical development and safety pharmacology; the planning and execution of clinical trials; clinical epidemiology, ethics, statistics and data management, as well as pharmacovigilance, pharmaceutical marketing and economics of health care.
The modular format and course structure (i.e. 3 full days every quarter) were specifically adopted to accommodate part-time students and those from out of town. The course is also open to students preparing for the Dip Pharm Med examination of the Faculty of Pharmaceutical Medicine (UK).
Each module is also offered as a stand-alone short course.
**please note that this course is based in South Africa**
Learning Outcomes
Module I: Introduction to Pharmaceutical Medicine
- Drug Discovery
- Principles of Clinical Pharmacology
Module II: Non-clinical Development of Medicines
- Pharmaceutical Development
- Non-clinical Safety Pharmacology and Toxicology
- Ethical and Regulatory Issues
Module III: Clinical Development of Medicines
- Clinical Development of Medicines
- Biometrics, Epidemiology and Data Management
Module IV: Pharmacovigilance, Marketing, Economics of Health Care
- Safety of Medicines and Pharmacovigilance
- Pharmaceutical Marketing; Economics of Health Care
Scientific Areas
Immunology and allergic disorders
Information management
PK/PD modelling
Target discovery and lead selection
Therapeutic Areas
Ageing
Cardiovascular disorders
Dermatologic disorders
Ear, nose, throat, and dental disorders
Endocrine and metabolic disorders
Eye disorders
Gastrointestinal disorders
Genitourinary disorders
Gynaecology and obstetrics
Haematology and oncology
Hepatic and biliary disorders
Infectious diseases
Injuries and poisoning
Musculoskeletal and connective tissue disorders
Neurologic disorders
Nutritional disorders
Psychiatric disorders
Pulmonary disorders
Language
English
Next Course Start Date
tba
Scholarship available
Yes
Course Location
Cape Town South Africa
|
Preclinical and Clinical Drug Development: Scientific, Regulatory and Ethical Aspects
|
Catholic University Medical School, Rome
|
Centre of Excellence |
Italy |
Catholic University Medical School, Rome
Largo Francesco Vito
1 - 00198 Rome
Italy
Contact
Lucia Lisi
+39 06 3051 4367
e-Mail
External Links
Course
Office
Course Description
This course is intended to provide the tools for a cultural latest in-depth knowledge of the process of drug development processes and the related clinical trials.
The availability of teachers coming not only from academia but also from different companies (national and multinational pharmaceutical industries based in Italy) and Italian Drug Agency will provide the most relevant information provided by experts directly involved 'in the field ', each in their own areas of expertise.
Language
Italian
Next Course Start Date
tba
Scholarship available
No
Course Location
Rome Italy
|
Principles of Identifying and Recognizing Adverse Events and Safety Signals
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives:
To enable students to develop an understanding of current practice in identifying adverse drug reactions and safety signals
To be able to classify events, identify signals and understand the follow-up procedure
Topics covered:
Definition of adverse drug reactions - type of ADRs
Detection and recognition of adverse events in clinical trials
Adverse event coding principles and differences
Spontaneous reporting databases
Principles of signal detection on electronic health care databases
Risk management plans
Scientific Areas
Information management
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Principles of Pharmacoeconomics and Valuation of Health States
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
contact@eu2p.org
e-Mail
External Links
Course
Fees
Office
Course Description
pricing and reimbursement purposes. Insight in the strengths and weaknesses of the different economic evaluation techniques is needed for improved decision making on medicines.
The objective of this module is to gain insight into different preference valuation techniques and (pharmaco)economic evaluation methods.
The topics covered in this module are:
Introduction
Costs
Effects
Pharmacoeconomic analysis
How to perform a good pharmacoeconomic evaluation
Learning Outcomes
At the end of this module, trainees will be able to:
- Describe the elements and scope of Health Technology Assessment (HTA)
- Execute a cost study and how to take into account the perspective in such studies.
- Calculate the different effect measures used in pharmacoeconomics
- Describe the different approaches for valuation of health states and to interpret these values
- Conduct a pharmacoeconomic analysis including all relevant aspects(incremental cost-effectiveness ratio (ICER), type of outcome analysis including differential timing, health outcomes models, and sensitivity analysis)
- Evaluate the quality of a pharmacoeconomic evaluation study
- Design a pharmacoeconomic study (extended version)
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Principles of Pharmacovigilance
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Office
Course Description
Objectives
To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-authorisation environment and the roles of various stakeholders within pharmacovigilance.
Topics covered:
Introduction to pharmacovigilance principles
Safety evaluation during a products lifecycle
Labelling and risk management
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Project Management in the Life Sciences Industry
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
This online course focuses on projects in the life sciences industry and the clinical trial setting, with the aim of bringing new treatments to patients successfully.These projects can range from early pre-clinical projects, to managing toxicology and Entry Into Human studies, large phase III clinical trials and post-marketing studies. All of them share a high complexity and require professional management at every level by experienced project managers who know the processes to reach the deliverables, can deal with multiple stakeholders simultaneously and deliver projects successfully often under a tight given budget and timelines.This highly interactive workshop setting includes a mixture of instructor led training and group work on real life cases. All templates and tools for planning, executing, managing amp controlling as well as closing a project will be developed. In addition participants have the opportunity to discuss and work on an own project, identify its challenges and develop solutions or work on a model project provided by the course instructors.
Learning Outcomes
bullTo understand the tasks and responsibilities of a project managerbullTo know the major project documents required for conductingprojects successfullybullTo be acquainted with the tools to manage all knowledge areasthroughout all project phasesbullTo build, lead and manage effective project teamsbullTo be familiar with the interactions needed with differentproject stakeholdersbullTo have a series of templates and tools at handbullTo be able to use and/or adapt these templates and tools withinindividual projectsbullTo know how to practically apply different project managementstandards to all kinds of pharmaceutical development projects
Language
English
Course Length
6 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
QPPV Tool Box Advanced Virtual Live Workshop: Your Key to Success
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
Reviewing and Understanding Clinical Papers
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
The practice of evidence-based medicine means integrating the current best research evidence with clinical decision making. Research evidence is one of many factors that are important when making healthcare decisions. Critical appraisal provides a systematic and objective way of examining research evidence in terms of its quality, validity, and relevance of results to specific situations. It provides a balanced assessment of the benefits and strengths of research against its flaws and weaknesses. As well as incorporating the theoretical foundation, the programme includes interactive sessions with practical techniques to enable participants to draw strong evidence based conclusions.
Outline
- Awareness of key study design and basic statistical concepts
- Understanding of the critical appraisal process
- Practical experience in applying critical appraisal
- Gain additional skills in drawing conclusions on research findings
- An appreciation of the rationale behind Evidence Based Medicine
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
- Integrate key date for critical appraisal in individual personal practice
- Assemble appropriate instruments and resources for use in critical appraisal, and apply these tools to appraise published research and judge reliability
- Formulate and manage effective individual personal information searching skills
Language
(Afan)/Oromoor/Oriya
Next Course Start Date
tba
Scholarship available
No
Course Location
Southampton United Kingdom
|
Risk Benefit Assessment in Pharmacovigilance
|
Drug Safety Research Unit
|
PharmaTrain Course |
United Kingdom |
Drug Safety Research Unit
Bursledon Hall
SO31 1AA Southampton
United Kingdom
Contact
Fiona Coxsell
e-Mail
External Links
Course
Fees
Course Description
Introduction
Risk benefit assessment is vital during the whole life cycle of products. For each medicine there is a balance between risk and benefit, but the perspective of different stakeholders (regulator, marketing authorisation holder, academic, patient, or prescriber) may vary. This course provides solid practical foundations which enable delegates to explore the relationship between risk and benefit, plus review the integration of appropriate strategies within risk management plans. Attendance at this course can be used as part of the training required for Higher Medical Training (HMT) and Pharmaceutical Medicine Specialty Training (PMST).
Aims
- To develop knowledge and understanding of the principles of risk benefit assessment, plus methods available for quantitative risk -
benefit analysis and their practical application in decision making
- To critically analyse factors associated with drug safety signals, the appropriate application of signal detection methodology and its contribution to safety monitoring and risk management
- To critically appraise with current regulatory legislation and guidelines relevant to risk management plans and recognise and justify their importance in helping ensure patient safety
- To analyse and review relevant documents for communicating risk benefit (including patient information leaflets, data sheets and safety alerts)
- To analyse recent challenges faced by regulators and marketing authorisation holders, critically review lessons learnt and outline future strategies for optimising pharmacovigilance activities to prevent withdrawal from the market
This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.
Learning Outcomes
On completion of this course delegates should be able to:
- Analyse and evaluate a safety signal
- Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information
- Differentiate between the various regulatory actions possible to address drug safety signals
- Recommend and justify options for crisis management of a safety signal
Language
English
Next Course Start Date
tba
Scholarship available
No
Course Location
Farehem United Kingdom
|
Risk Management Plan (EU-RMP) Creation Virtual Live Training Course
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
Scientific Medical Writing (Online or Face to face)
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
41 61 267 19 50/52
e-Mail
External Links
Course
Office
Course Description
nbspBrush up your scientific and medical writing skills. Learn how to structure scientific papers and reports and write a clear and informative scientific text. This course provides a comprehensive overview of the strategic scientific and medical writing field and offers hands-on training in writing and analyzing scientific texts.This course will coverWhat is the correct strategic approach to writing successful documentsHow to convey a message to the target audienceHow to produce high-quality documentsWhat are the requirements to reach a successful outcomeEthics of scientific writingPractical work with multiple exercise
Learning Outcomes
By the end of the course, students will be able toKnow key elements of good medical and scientific writingCritically appraise texts and identify elements of poor writingConvert some examples of poor writing to good scientific writingReproduce the most important aspects of good medical and scientific writingImprove own texts
Language
English
Course Length
2 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
Basel Switzerland
|
Signal Management in Pharmacovigilance Virtual Live Training Course
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
Study Trip
|
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
|
Centre of Excellence |
Switzerland |
University of Basel - European Center of Pharmaceutical Medicine (ECPM)
Klingelbergstrasse 61
4056 Basel
Switzerland
Contact
Annette Mollet
4161 2071950/52
e-Mail
External Links
Course
Fees
Office
Course Description
A total of six study half-days are planned (theory and visits to institutions). The program will be available soon.Introduction into the health systemVisits of hospitalsInsurance companiesPharmaceutical industryAfter the trips to Singapore (2015, 2016), Israel (2017), Denmark (2018), and Canada (2019) the destination of the study trip 2022 is Estland.
Learning Outcomes
Learn how different health care systems functions and who are the key stakeholders
Language
English
Course Length
6 Day(s)
Next Course Start Date
tba
Scholarship available
No
Course Location
depending on the country chosen Switzerland
|
Substantiation and Quantification of Risks
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To enable students to design studies, write protocols
To quantify and analyse safety signals or risks
To understand the potential and limitations of post marketing hypothesis testing studies
Topics covered:
Introduction: from case based reasoning to population based reasoning, examples: Augmentin, H1N1 vaccination, Yellow fever vaccine
Theory of causality: causality from different perspectives, validity & causal diagrams, plausibility & substantiation
Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol
Data analysis: SAS, raw data to metrics, elementary and advanced analysis, controlling confounding, Bayesian methods, sensitivity analysis, meta-analysis
Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
The Pharmacovigilance Quality Management System
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
The Pharmacovigilance Quality Management System
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
The Pharmacovigilance Quality Management System Virtual Live Training Course
|
Drug Information Association
|
PharmaTrain Centre |
|
Drug Information Association
Küchengasse 16
4051 Basel
Switzerland
Contact
External Links
|
The Public Health Impact of Adverse Drug Reactions
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives:
To critically use data from experimental and observational studies to evaluate the public health impact of selected adverse drug reactions.
To design and to carry out an analysis of the impact of adverse effects at a community level.
To analyse the economic impact of adverse drug reactions on public health.
Topics covered:
Data generalization: from particular cases to population impact-1. The interpretation of the results of clinical trials and meta-analyses from the public health point of view
Data generalization: from particular cases to population impact-2. Examples of the value of observational studies and meta-analyses of observational studies in the evaluation of the public health impact of medicines use.
Public health impact - Case: Hormone replacement therapy
Public health impact beyond case-control studies
The importance of the denominator: case-population studies. The future of pharmacovigilance.
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)
|
Valorisation and Critical Appraisal in Research
|
Eu2P
|
PharmaTrain Centre |
World Wide (Distance Learning) |
Eu2P
146 rue Léo Saignat
33076 Bordeaux
France
Contact
Eu2P Office
+ (33) 5 57 57 92 57
e-Mail
External Links
Course
Fees
Office
Course Description
Objectives
To improve your scientific communication skills such as:
Redaction of scientific original papers and reports
Realization of a scientific poster
Preparation of a scientific oral communication
To become familiar with the institutions and data sources in Health Sciences
To become familiar with the research funding
Objectives
To improve your scientific communication skills such as:
Redaction of scientific original papers and reports
Realization of a scientific poster
Preparation of a scientific oral communication
To become familiar with the institutions and data sources in Health Sciences
To become familiar with the research funding
Language
English
Next Course Start Date
Anytime
Scholarship available
No
Course Location
World Wide (Distance Learning)