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Cooperative European Medicines Development Course (CEMDC)

Sándor Kerpel-Fronius, M.D., D.Sc.Semmelweis UniversityDepartment of Pharmacology and PharmacotherapyBudapest, HungaryEmail: kerfro@pharma.sote.hu

WP5 Geographical Extension Project

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Cooperative European Medicines Development Course (CEMDC)

• Czech Republic• Estonia• Greece• Hungary• Lithuania• Montenegro• Poland• Portugal• Romania• Serbia (Belgrade

and Novi Sad)• Slovakia• Slovenia• Turkey

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Organogram of the CEMDC

Participating universities Supervision of administration.

Delivery of the educatinal program

PharmaTrain

Harmonised educational program

Quality Assurance

International Advisory Board

GOVERNING BOARDCoordinating University

Study Director Quality Assurance

Educationa Committee

Module LeadersStudy Management

Group

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Joint student group

Joint educational staff

Organization of joint education

All the teaching activities will be done jointly for all the enrolled students by a joint educational staff

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IMI-Pharmatrain course structure

Base course (6 base modules, 30 ECTS)

1. Introduction. Drug discovery2. Non-clinical drug development3. Early clinical drug development4. Confirmatory clinical drug trials5. Drug regulation and

pharmacovigilance6. Healthcare, marketplace,

economics of healthcare

Six additional modules, 30 ECTSExtension modules1. Pharmacoeconomics , drug reimbursement2. Drug safety, pharmaco- epidemiology, pharmacovigilance, risk management 3. Biological medicinal products and advanced therapies4. Specific patient populations Eligible modules5. Generic and biosimilar medicinal agents6. Development of medicinal devices

Base course Master course