Course Description

Cooperative European Medicines Development Course (CEMDC) - under discussion www.semmelweis.hu/cemdc The need to provide high-quality and cost-effective medication for mankind living in various countries led to the intensive globalization of the research and manufacturing of medicines. The global need for properly educated professionals with a broad education covering all aspects of medicine development can be primarily provided by highly complex life-long continuous professional training. Unfortunately countries with smaller populations and/or small size pharmaceutical industry cannot provide and maintain this education cost-effectively for a prolonged time. For covering their needs the Cooperative European Medicines Development Course (CEMDC) was organized with the participation of 10 regional universities. (Estonia, Hungary, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Turkey) The PharmaTrain harmonized European course program is used for the teaching. The aim of the course scientifically accredited by PharmaTrain and IFAPP is to train experts who understand the complex process of medicines development from molecule to health care and who can apply this knowledge working in large or small, innovative or generic pharmaceutical companies, small and medium sized enterprises, regulatory agencies as well as in health care and health insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care. The training is given in English. Students can apply with a diploma of medicine or pharmacy, MSc or equivalent degrees in natural or life sciences. A satisfactory English knowledge is needed to follow the program. The course is open for students of all nationalities The modules of the course can be visited individually according to the interest of the applicant. Each modules are finished by examination. Employers are encouraged to support this effort to train highly qualified experts for the development of better medicines by giving them some free time and, if possible, financial assistance to follow the course. Instead of providing fellowship the course fee can be reduced upon negotiation in limited cases. Further information For additional information concerning the education plan, participation fee, registration and contact details please consult: http://www.semmelweis.hu/cemdc/about-courses/ Information on the CEMDC and PharmaTrain can be found on the same website: www.semmelweis.hu/cemdc

Course Description

The Diploma of Advanced Studies (DAS) in Pharmaceutical Medicines program provides specialist knowledge in the field of drug development at an advanced level. The syllabus of the course program covers all aspects of pharmaceutical medicine and drug development as defined by the International Federation of Associations of Pharmaceutical Physicians (IFAPP, www.ifapp.org).

This includes the discovery and development of new medicines, clinical trial methodology, good clinical practice and ethics, pharmacovigilance and epidemiology, biostatistics, regulatory affairs, health economics, project management, marketing and new therapeutic approaches.

After having successfully completed the DAS program with 30 ECTS, training can be complemented with further learning elements to achieve a Master of Advanced Studies in Medicines Development.

The course program is divided into six modules consisting of four days each over a period of two years. Learning methods comprise online preparation, lectures and group work on case studies. The course language is English.

The ECPM Advanced Studies degrees are targeted at representatives from the pharmaceutical industry, service industry, academic and government decision- and policy-makers who already have a good understanding of the basics of drug development and will benefit from a more in-depth, comprehensive and systematic immersion into modern medical product and device development, regulation and market introduction.

Course Description

Overview Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of the marketing of medicines for the benefit of patients and the health of the community. In this rapidly expanding field of medicine there is a need for high quality education programmes that are compliant with the PharmaTrain initiative of the European Commission, but also with the Bologna Process. The programmes at King’s are the first in the UK that meet both of these requirements. This, plus the opportunity to study at a world class university makes King’s the ideal place at which to study for one of these MSc subjects. Clinical Pharmacology is the study of how drugs influence human physiology and the way the body handles drugs. It is a vital part of the early clinical development of new medicines. It requires an understanding of preclinical science, ethical and legal requirements for clinical research programmes and how to design and interpret individual clinical trials. A well designed clinical pharmacology programme informs the final regulatory of a new medicine. Generating skilled clinical pharmacologists is therefore vital to ensure that new medicines are efficiently developed. Translational Medicine is an emerging and highly topical discipline that involves the translation of science from the bench to the bedside, and much of this is focussed on novel drug therapies. The bank of in vitro, pre-clinical and human testing required to do this often leaves scientists bemused, but experts in translational medicine can plot a pathway to enable the very best therapies to be tested in human subjects. The MSc programmes will not only equip the students with a broad knowledge and understanding of the whole of the drug development process and the medical aspects of the marketing of pharmaceutical products but also give them the opportunity to undertake a research project that will enable them to apply these skills and should lead to one or more publications. Key benefits - King's is ranked 4th in the world for Pharmacy & Pharmacology (QS World University Rankings by Subject 2016) - Programmes align with the PharmaTrain and the Faculty of Pharmaceutical Medicine curricula. - Flexible programmes with a part-time option that allow you to fit the modules in with your work schedule. - Teaching given by leading experts from the academic staff of King’s College London, from the biopharmaceutical sector and the regulatory authorities. Course detail Description Gain the skills to evaluate, plan and execute the studies involved in taking a new medicine from the exploratory clinical development phase through to the point of applying for marketing approval, including regulatory processes. One of three modular programmes in Pharmaceutical Medicine designed for working physicians, clinical scientists and allied health professionals. Course purpose This programme is for those working in or seeking to work in the field of clinical drug development. It covers all aspects of the clinical development process through from the earliest studies to post marketing activities. It will enhance knowledge and skills in all aspects of clinical research, drug regulation and drug safety. Further literature Please send an email to Hayley Kelly at pharm-med@kcl.ac.uk to request an application form for part-time or standalone modular study. Course format and assessment Three assignments plus one online multiple choice test for each module. Extra information Each module in this programme is delivered as a distinct, intensive 4 or 5 day taught course, plus pre- and post-course reading and assignments. Each module can also be taken as a standalone module.

Course Description

The Eu2P Master is an academic post-graduate diploma in pharmacovigilance and pharmacoepidemiology jointly delivered by the seven European academic bodies working together as Eu2P partners. The Eu2P European Master is built and recognised by all the 24 academic, regulatory and industrial Eu2P partners. Eu2P courses are grounded in real job market and today's practices and research projects can be performed in public or private environments. Eu2P programme is being noticed and recognised world-wide* as an excellent opportunity to get jobs and improve regulatory sciences. In second year, choose a Master specialization among Benefit assessment of medicines, Medicines risk identification and quantification, Medicines benefit-risk assessment, Medicines and public health, Medicines risk communication domains or select "à la carte" modules to match specific needs. Awarded for e-learning quality, Eu2P online courses can be attended at home and work. See Eu2P Training Excellence : http://www.eu2p.org/study-with-eu2p/training-excellence Master year 1 or 2 curriculum can be performed on a full or part time basis to suit your time availiability. Scholarships and fees discouts can be offered under eligibility conditions.

Course Description

Currently the 3rd term is to start in April 2023 and is open for trainee enrollment.The 1st termOct 2020 to Sept 2021.The 2nd term Jan-Dec 2022.nbspnbsp

Course Description

The goal is to provide a complete master of interdisciplinary training on all aspects of scientific, regulatory, ethical, organizational and promotional development of a new drug. The content and structure of the Master is consistent with the Core Curriculum Syllabus of the Faculty of Pharmaceutical Medicine and at the end of the first edition (2008-2009) will then have the international recognition of the Council for Education in Pharmaceutical Medicine

Course Description

The European Center of Pharmaceutical Medicine (ECPM) designs and organizes the Master of Advanced Studies in Medicines Development program, together with partnering universities throughout Europe and other health care partner organizations. The program emphasizes integrated drug development, which is science-based, innovative, efficient and of high quality – leading to better and safer medical products for patients.

It is targeted at representatives from the pharmaceutical industry, service industry, academic and government decision- and policymakers who already have a good understanding of the basics of drug development and will benefit from a more in-depth, comprehensive and systematic immersion into modern medical product and device development, regulation and market introduction.

The program is structured in modules, which allows it to be completed next to working full- or part-time. Students can enroll in both the ECPM course and the master program.

In total, the Master of Advanced Studies requires a minimum of 60 ECTS.

30 ECTS (6 modules, triple exam) will be accredited by successfully completing the two-year ECPM Diploma Course - a well-established postgraduate education and training program - and acquiring the Diploma of Advanced Studies (DAS).

20 ECTS will be accredited for completing the master modules selected from the Continuing Professional Development (CPD) short courses list. These can be chosen by preference either from the ECPM CPD short course program, from other course providers or partner universities which offer training relevant to drug development sciences and the IMI PharmaTrain syllabus.

The remaining 10 ECTS will be accredited for writing and submitting a master thesis.

Course Description

This course offers high-quality and practical training for employees in clinical research. In a part-time manner, you will be prepared for a management position. The course imparts scientific competencies that are in high demand and are necessary for the planning, execution and evaluation of clinical trials with drugs and medical devices. An internationally required level of education is combined with interactive courses and the integration of practitioners, experts from clinical research and other relevant disciplines.The university course is accredited by AHPGS and PharmaTrain. The lecturers of this university course are distinguished experts and Practitioners from relevant disciplines (clinicians, CRAs, etc.). This particular ensures that the connection to current clinical research practice is as close as possible. It also enhances the career opportunities of the university course graduates in this high-grade, transnational field.

Course Description

In the health sector the realization of globalization of markets is already well advanced. Great effort is being made to harmonize research guidelines, require­ments for registration data and health politics. Mega mergers of pharmaceutical companies are simultaneously the result and accelerator of this development. Associated with these processes we recognize an enormous change within the institutions of the health care system and the pharmaceutical industry. In order to meet the challenges of this process in Europe it is necessary to build up an innovative education concept for peo­ple able to fulfill the demands of the future. Perceiving this situation the curriculum for the postgraduate study course Pharmaceutical Medicine was developed and after approval implemented. The objective of this study course is to focus on day-to-day practice, to promote interdisciplinary knowledge and to enable the participants to deal with the complex international tasks facing health care institutions and the pharmaceutical industry. The genaral objectives of this course are: - To give the participant an integrated overview of all relevant topics within the health institutions and the pharmaceutical industry. - To educate physicians and scientists in all major aspects of drug research and development, with emphasis on clinical development. - To stimulate an insight into the pitfalls and possibilities of research and development with a new chemical entity. - To present the health economic environment and its implications for drug development. to create an educational platform that enables the participant to fulfil and understand a variety of roles within the health institutions and the pharmaceutical industry. - To make the participant aware of various aspects of social competence as well as of the scientific, ethical and social role of the clinical scientist in professional teams within the health institutions and the pharmaceutical industry. - To train the participant in moderation and leadership of groups. - To increase the communicative skills of the candidate.

Course Description

The Catholic University of Sacred Heart, at the initiative of the Faculty of Medicine and Surgery "A. Gemelli" (in collaboration with the Society of Applied Pharmacological Sciences, SSFA, Viale Abruzzi 32-20131 Milano, Tel 02-29536444 - Fax 02-89058506 - E-mail: ssfaseg@tin.it ) for the academic year 2011/2012 establishing the second level University Master in "Development of preclinical and clinical drug: technical-scientific, regulatory and ethical." The second level university Master lasts one academic year for a total of 60 credits, equivalent to 1500 hours. The Master in "Development of preclinical and clinical drug: technical-scientific, regulatory and ethical" 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.

Course Description

Course Details This M.Sc. course is administered by the Department of Pharmacology and Therapeutics, in the Trinity Centre of Health Sciences, St James's Hospital, Dublin. It has been developed to provide medical and science graduates with specialist knowledge and skills in the area of clinical pharmacology and pharmaceutical medicine. In-take is on an annual basis. Components of the course include principles of: - Pharmacology and biostatistics - New drug development and the regulatory environment - Pharmacoeconomics and rational use of drugs - Pharmacovigilance and drug information The course involves completion of taught modules and the additional undertaking of a research project. The modules consist of formal teaching and personal assignments and are run over five terms on a part-time basis (approximately two modules per term). Some of the modules are undertaken by way of distance learning. In addition, the students are assigned a research project (including field work), to be submitted as a dissertation for the degree of M.Sc. only. The syllabus is compliant with PharmaTrain, an EU funded Innovative Medicines Initiative (www.pharmatrain.eu). Students are assessed by way of continuous assessment and are required to pass written and oral examinations at the end of their course. In addition, they are required to submit a written dissertation on their research project (with the possibility of an oral examination) by the end of the second year of the course. Prospective students for this course must hold a primary degree in either medicine or another relevant health or science subject. Candidates should have a minimum of two years' practical experience in their area of qualification/pharmaceutical industry. The course is run in the Trinity Centre for Health Sciences, St. James's Hospital, Dublin 8.

Course Description

The PHARMED (recognized as a PharmaTrain Centre of excellence) programme follows closely the syllabus for Pharmaceutical Medicine/Medicines Development Science issued by PharmaTrain. It consists of 6 course modules spread over two years.Launched in 1992, the PHARMED program covers the entire drug development process, from drug discovery to market access.nbspThe program was reviewed and updated to incorporate the latest innovation and new developments in the sector.MDs, pharmacists, doctors in veterinary medicine, and those with post-graduate qualifications (masters, PhD) in life sciences are eligible to enrol. PHARMED is designed for those wishing to train for a future career in the pharmaceutical industry, as well as for people already working in the biopharmaceutical industry who want to develop or update their knowledge.The PHARMED program is made up of 6 distance learning modules covering the entire drug development process, from drug discovery to market access, along with a seventh, elective, module covering a specialist subject. Each of the 6 general modules will be followed by a workshop and a written assignment.The teaching team is composed of experts from various universities, regulatory authorities/agencies, CROs, pharmaceutical and biotechnology companies.The course is delivered in an interactive lecture format. Each module will conclude with a workshop in which participants will work on a case-study in small teams, supported by one or more members of the teaching team. Participants will be able to download documents before the workshop in order to prepare. The group will be tasked with developing a strategy, and students will submit an individual report (assignment) one week later.All distance learning courses are recorded as videos and can be watched again, accompanied by slides, on the course platform. The course is delivered in English.A ldquoCertificate in Pharmaceutical Development Sciencesrdquo is awarded to candidates who successfully pass the three-part examination- Six assignments- Multiple choice exam- Oral exam on the full range of topics covered by the programA new edition A new edition started in January 2023.Against todayrsquos backdrop of a constantly evolving biopharmaceutical industry, course providers must offer flexibility. This is why PHARMED provides different ways to study the program- Attend the full distance learning course of 6 modules (1) over 2 years- Study individual module(s) (with access to corresponding recordings) - see CDP courses.Please contact us for further information pharmed.helsciulb.be

Course Description

Dieser Lehrgang fokussiert auf die wesentlichen Arzneimittelentwicklungsbereiche von praeklinischen Analysen ueber das klinische Entwicklungsprogramm bis zur Marktzulassung und der Marktueberwachung. Nach Lehrgangsende haben Sie umfassendes Know-how ueber alle Entwicklungsbereiche und kennen in allen Phasen das notwendige rechtlich-/regulatorische Rahmenwerk. Damit sind Sie in der Lage, sich selbst aktiv in die Arzneimittelentwicklung einzubringen, da Sie die notwendigen Zusammenhaenge verstehen und Anforderungen in den jeweiligen Kontext setzen koennen. Der Lehrgang enthaelt Elemente des Selbststudiums via e-learnings, kurze Live-Webcasts und ganztaegige Online-Seminare, um den gesamten Entwicklungsbereich abzudecken und gleichzeitig zeitliche Flexibilitaet zu ermoeglichen. Die e-learnings schliessen mit einem Online-Test ab, bei Bestehen aller 9 Online-Tests wird ein Gesamtzertifikat erteilt.