XX.YY.2012/1 Cooperative European Medicines Development Course (CEMDC) Sándor Kerpel-Fronius, M.D., D.Sc. Semmelweis University Department of Pharmacology.

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XX.YY.2012/1 Cooperative European Medicines Development Course (CEMDC) Sándor Kerpel-Fronius, M.D., D.Sc. Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest, Hungary WP5 Geographical Extension Project

XX.YY.2012/2 Cooperative European Medicines Development Course (CEMDC) Czech Republic Estonia Greece Hungary Lithuania Montenegro Poland Portugal Romania Serbia (Belgrade and Novi Sad) Slovakia Slovenia Turkey

XX.YY.2012/3 Organogram of the CEMDC

XX.YY.2012/4 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

XX.YY.2012/5 IMI-Pharmatrain course structure 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 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 Master course