1. Cooperative European Medicines Development Course (CEMDC)
WP5 Geographical Extension Project
Cooperative European Medicines Development Course (CEMDC)
Sándor Kerpel-Fronius, M.D., D.Sc.
Semmelweis University
Department of Pharmacology and Pharmacotherapy
Budapest, Hungary

2. Czech Republic, Prague?
Estonia, Tartu
Hungary, Budapest
Lithuania, Kaunas
Poland, Warsaw
Portugal, Lisbon
Romania, Targu Mures
Serbia, Belgrade
Slovakia, Bratislava
Slovenia, Ljubljana
Turkey, Ankara

3. Organogram of the CEMDC
Participating universities Supervision of administration.
Delivery of the educatinal program
PharmaTrain
Harmonised educational program
Quality Assurance
International Advisory Board
GOVERNING BOARD
Coordinating University
Study Director
Educationa Committee
Module Leaders
Study Management Group

4. Organization of joint education
Joint educational staff
Joint student group
All the teaching activities will be done jointly for all the enrolled students by a joint educational staff

5. IMI-Pharmatrain course structure
Base course Master course
Six additional modules,
30 ECTS
Extension modules
1. Pharmacoeconomics , drug
reimbursement
2. Drug safety, pharmaco-
epidemiology, pharmacovigilance,
risk management
3. Biological medicinal products and
advanced therapies
4. Specific patient populations
Eligible modules
5. Generic and biosimilar
medicinal agents
6. Development of medicinal devices
Base course (6 base modules,
30 ECTS)
1. Introduction. Drug discovery
2. Non-clinical drug development
3. Early clinical drug development
4. Confirmatory clinical drug trials
5. Drug regulation and pharmacovigilance
6. Healthcare, marketplace, economics of healthcare

6. Base Course Covering all topics of the syllabus
2. Development of Medicines: Planning
3. Non-Clinical
Testing
1. Discovery of
Medicines
4. Pharma-
ceutical
development
Base course (6 base modules, 30 ECTS)
1. Introduction. Drug discovery
2. Non-clinical drug development
3. Early clinical drug development
4. Confirmatory clinical drug trials
5. Drug regulation and pharmacovigilance
6. Healthcare, marketplace, economics of healthcare
14. Therapeutics
13. Economics
of Healthcare
5. Exploratory
development
6. Confirmatory
development
12. Information,
promotion
7. Clinical
trials
11. Drug Safety
10. Regulatory
affairs
9. Data management
Statistics
8. Ethics
legal issues

7. Modular structure and assessment
Modular organization
5 ECTS/module
working hours/module
50-60 hours pre-module preparation
25-30 hours F2F teaching
50-60 hours post-module assignment writing
Assessment at the end of each module:
20-25 MCQs
50% evaluating learning of pre-module preparatory materials
50% evaluating the understanding of the lectured material
1-2 assignments ( words)
Final note : combined assessment of MCQs + assignments, each part must be passed
MODULAR
Module
ASSESSMENT

8. Integrated asessment at the end of the Base Course
Optional but
strongly
recommended
by PharmaTrain
INTEGRATED
Base course (6 base modules, 30 ECTS)
1. Introduction. Drug discovery
2. Non-clinical drug development
3. Early clinical drug development
4. Confirmatory clinical drug trials
5. Drug regulation and pharmacovigilance
6. Healthcare, marketplace, economics of healthcare
MCQ with marker MCQs
Optional methods
1-2 short, 2 pages
long assays
Discussion of scientific paper s
PhT external examiners
ASSESSMENT

9. PharmaTrain CPD Platform also prepares for Integrated Examination and the Specialists Titles
WP2
This slide needs technical improvement. I cannot enter it.:
say: „examination“ instead of „exam“
- under the red line it should say „postgraduate“
under the red line the „t“ for „trainng“ needs to go into the next line
Grundsätzlich erschließt sich mir diese Abbildung nicht. „Third tier“ wird hier nicht klar. Sowohl für den Specialist of medicines Development als auch für den specialist of Pharmaceutical Medicine ist doch eine praktische Berufszeit erforderlich – oder? Für den Nicht-Mediziner wohl kürzer als für den Mediziner – aber diese praktische Zeit sollte graphisch deutlich gemacht werden.
Die Abkürzungen „SMD“ und „SPM“ sind nicht glücklich, weil ein Aussenstehender bei „SMD“ eher an den Mediziner denkt.
WP7a
Additional practical
work is needed

10. Timing of further preparatory work
Planned initiation of the CEMDC teaching (January, 2013) ???
Further preparatory work required (2012 November)
Finalization of the teaching plan
Listing of preparatory materials
Case presentations
Assignment titles
Advertisement, student recruitment
Investigators Training (CLIC)

11. How to manage the MSc course within the PhT cooperation
Only few students register for a Master Course according to the experience of other PhT courses
The Semmelweis University course finished the entire 2 years program
Teaching of 12 modules
Defense of a thesis
How to manage advanced modules within the PhT cooperation
Offer the topics as a self-standing modules. Some modules might attract larger number of students providing income
The participating course providers might cooperate to offer the master course jointly by presenting only selected modules which together build up the entire program
The five ECTS following successful modular examination can be added up for obtaining a MSc at a selected PhT course offering MSc