Overview about Shared Standards in PharmTrain

PharmaTrain partners have achieved Shared Standards for Courses and single Modules for the following items:

  1. Modular Course Structure based on Bologna Principles and ECTS System incl. definition of Diploma (Base) Course, Master Programme, Elective and CPD 
  2. Syllabus 
  3. Curriculum
  4. Learning Outcomes 
  5. Modular Assignments and Course Assessments 
  6. Quality Management System
  7. e-Library and e-Campus 


PharmaTrain partners are providing:

Diploma (Base) Courses in Medicines Development
Master Programmes in Medicines Development
Continuous Professional Education Courses 

Please note that the Courses and Modules listed on the above mentioned three pages will be updated in spring 2012. By then, the PharmaTrain courses will be taken from the “On-Course” data base developed by the partner project “EMTRAIN”, one of the other five IMI JU “Education & Training (E&T) Projects.

PharmaTrain will strive to maintain and to improve the standards and quality of courses through a quality management and improvement framework. The programme will encourage exchanges between the industry, regulators and academia. It will produce and promote e-learning programmes and so increase flexibility, transferability and mobility of participants. By providing a database of available education and training programmes at different levels across Europe, PharmaTrain will identify available courses, and map regions and subjects where gaps exist that should be addressed

Modular Course Structure

Summary of Shared Standards and definitions
please find a Glossary here

1    Bologna principles and ECTS System
PharmaTrain is fully based on the Bologna process, which is well established in Europe. PharmaTrain relies on the European Credit Transfer and Accumulation System, ECTS: 1 ECTS = 25-30 student investment hours.

Modular Structure of PharmaTrain Diploma (Base) Courses, Extension and Integrated Master Programmes (Master of Medicines Development, MMD)

Definition of a Module
A PharmaTrain Module (5 ECTS) is characterised as follows:
  • Usual duration 4 days face-to-face course at a university centre (2 ECTS)
  • Pre-Course work and (e-)preparation (1 ECTS)
  • Post-Course work: research, reading, assignments (2 ECTS)
  • Modules usually have assessments at the end of the Module.

Diploma (Base) Course, DIMD: 30 ECTS, 6 x 5 ECTS modules, Syllabus is covered. It has the following Curriculum:
Module 1a    Introductory course
Module 1b    Drug discovery & development planning
Module 2    Non-clinical testing, pharmaceutical & early clinical development
Module 3    Exploratory & confirmatory clinical development
Module 4    Clinical trials
Module 5    Regulatory affairs, drug safety & pharmacovigilance
Module 6    Healthcare marketplace & Economics of healthcare

An Introductory ‘Module One’ (two of the four days of module one) will contain the core subjects of the PharmaTrain Syllabus, covering in a standardised format the context for the more detailed modules to follow. It is adopted by all PharmaTrain programmes and is designed

Master in Medicines Development, MMD: 60+ ECTS, 12 modules either as:

Integrated Master Programme (12 modules, no exit at 30 ECTS), 10 modules are mandatory, 2 modules can be taken from a list of recommended courses (=Electives)
or
Extension Master Programme: 30 ECTS Base (Diploma) Course + 4 mandatory Extension Modules + 2 modules taken from a list of recommended courses (= Electives)
The four mandatory Extension Modules have the following topics:
Ext 1: Health economics
Ext 2: Drug Safety, Pharmacoepidemiology, Pharmacovigilance, Risk Management
Ext 3: Biologcials and Advanced Therapies
Ext 4: Vulnerable Diseases and Clinical Trial Practices

Thesis: 15-20.000 words – research / literature review based (dependant on the course providing university)

Electives
An Elective is defined as a module which can be used to complete the Masters Degree i.e. in addition to the Extension Modules (Extension Master) or as part of the Integrated Masters Programme. An Elective can be passed as one of the 12 mandatory modules to achieve a Masters Degree. PharmaTrain will work on a defined list of Electives (WP3 and 6) which are well characterized in terms of Learning Outcomes and content. Course Providers may choose Electives for recommendation.

CPD Platform
The PharmaTrain CPD-Platform for Continuing Professional Development (CPD) includes elective and extension modules and stand-alone modules provided by PharmaTrain to facilitate lifelong learning. CPD modules are provided by universities but also from Learned Societies within PharmaTrain. CPD platform is available with approx. 100 products provided by the PharmaTrain partners on www.pharmatrain.eu.


IMPTHP_Elipsen_04_EE2.png



Fig.:This ‘ellipsogram’ depicts the 6 Diploma (Base) Course Modules and the additional 6 ‘Extension’ Modules of which two are electives (from the CPD platform) for the MMD (Extension Master Programme)

Syllabus

The PharmaTrain Syllabus for Pharmaceutical Medicine / Medicines Development provides the content for all education and training activities including Introductory, Base Diploma Course and Master Programme Modules. It covers the drug development process from discovery of a new chemical or biological entity through research and development to regulatory approval, pharmacovigilance, health economics, commercialisation and lifecycle management of a medicine (183 topics in 14 sections, + doc download)

Curriculum

The topics of the Syllabus have been allocated to the above mentioned Modular Structure (definition of the Curriculum Structure) and in the next step Learning Outcomes have been defined for all modules (8-15 Learning Outcomes / Module).

Learning Outcomes

Modular Learning Outcomes have been defined for the Base (Diploma) Course Modules and Extension Modules. Further Learning Outcomes will be defined for the list of Electives.

Modular Assignments and Course Assessments

Assessments include modular assignments. After the end of each module of the Base (Diploma) Course and Master Programme assignments have to be passed ((keywords: data set, critical analysis, review, “scenario based”, “ ECTS). Integrated Examinations are held after the end of the programmes (keyword: written paper, MCQ).

Implementation Process of Shared Standards

This “Implementation Process of Shared Standards” has been created to have a defined process in place which allows Course Providers (Diploma Base Courses and Master Programmes) to demonstrate the change of their courses and inclusion of PharmaTrain standards. In addition, courses which have awarded Center Recognition or Center of Excellence will be considered by EFPIA companies for additional course fees sponsorship as in-kind contribution.

The Implementation Process of Shared Standards is based on the concept of site visits of assessors at all course sites. If they feel prepared Course providers “call” the assessors trio teams for either a coaching or an assessment to, finally, achieve the Award as a Center Recognition or directly a Center of Excellence.

Quality Management System

A comprehensive Quality Management System supports and translates the principles and standards into training practice to ensure the quality of the training curriculum as well as the operation of the entire PharmaTrain programme

To achieve these PharmaTrain stamps the Implementation Process of Shared Standards for new and adapted training programmes.

e-Library and e-Campus

The PharmaTrain e-library integrates state-of-the-art newly developed blended learning modules with those collected from continuing survey to create a directory of online courses. The library is open to all partners, allowing them to blend the content into their modular courses in the way best suited to their institution. The repository will allow institutions to continue to develop more specialised extension modules, enhancing the learning experience by creating a holistic environment of teaching methodologies supporting the programme. In addition, this repository will evolve into a pan-European online e-campus, supporting faculty and students. Supporting material (e.g. book chapters, publications etc.) will be added and become part of the online repository.

e-modules ready to use
The following e-learning modules have been developed during the IMI PharmaTrain project ending April 2014. They are covering the medicines development process. The compact modules are linked to the PharmaTrain base courses in Pharmaceutical Medicine/Medicines Development science and can be used as a preparation before face-to-face sessions or as post-session reading. A password has to be required here.

  • Introduction
    (created by Hibernia, with the support of AZ, Pfizer and Pharmed)
  • Basis of formulating dose-response
    (created by Novartis and Hibernia)
  • Ethical issues in clinical research 
    (created by Hibernia)
  • New: Drug Safety
    (created by ECPM Institute of Pharmaceutical Medicine, University of Basel)
  • Registration of medicinal products 
    (created by Hibernia with support of PHARMED, Pfizer, BfArM and FAGG-AFMPS)
  • Health Economics 
    (created by UCB, Hibernia College, PHARMED and Pfizer)
  • Full Development of a Biological
    (using the example of Monoclonal Antibody) (created by Amgen with support of UCB, Pharmed and Semmelweis University)
  • A Therapeutic Module on Parkinson’s Disease 
    (created by Hibernia, Pharmed and UCB)
  • A Therapeutic Module on Asthma/COPD
    (created by Hibernia, Pharmed and UCB)

PharmaTrain has also created an online course for clinical investigators CLIC. It contains various modules of increasing depth that can answer the needs of sub-investigators and staff members, principal investigators and sponsor-investigators respectively.

  • Clinical Investigator Course
    (created by HSeT with the support of UCB, Pfizer, Novartis and Pharmed)