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In your studies 'Drug Regulator Affairs'

©DGRA e.V.

Study modules

MDRA-26 (academic year 2024/2025)

No.	Module	Credit points
01	Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice Teaching time ca. 30 hours, Study paper ca. 30 hours	5
02	Pharmaceutical Law Pharmaceutical law in Germany, the EU and other countries and related laws Teaching time ca. 30 hours, Study paper ca. 30 hours	6
03	International Registration Procedures Principles and procedures for the authorisation of medicinal products, diagnostics and medical devices in the EU, the USA, Japan and worldwide Teaching time ca. 45 hours, Study paper ca. 30 hours	7
04	General Aspects of Module 1 (CTD), Registration of Special Medicinal Products Formal requirements for authorisation and contents of Module 1 CTD, product information texts (summary of product characteristics, package leaflet), special requirements for special therapeutic indications, veterinary medicinal products, blood products, vaccines and advanced therapy medicinal products (ATMPs) Teaching time ca. 30 hours, Study paper ca. 30 hours	5
05	Maintenance of Marketing Authorisations / Pharmacovigilance Monitoring during use, advertising, product changes, amendment and renewal of authorisation Teaching time ca. 30 hours, Study paper ca. 30 hours	6
06	Information Management, e-CTD From literature research to the processing of documents and data to information evaluation and electronic submission Teaching time ca. 20 hours, Study paper ca. 20 hours	3
07	Quality Management / Medical Devices Good practice rules, international standards, quality assurance systems and control, medical device law Teaching time ca. 30 hours, Study paper ca. 30 hours	5
08	Chemical Pharmaceutical Documentation Documentation from synthesis to analysis, pharmacopoeia monograph, dosage form and production Teaching time ca. 30 hours, Study paper ca. 30 hours	6
09	Pharmacology and Toxicology Documentation Documentation of pharmacology, toxicology, genotoxicity and ecotoxicology Teaching time ca. 30 hours, Study paper ca. 30 hours	6
10	Clinical Documentation Documentation of drug trials on humans, clinical trial samples, observational studies and experience reports Teaching time ca. 30 hours, Study paper ca. 30 hours	6
11	Benefit, Efficiency, Reimbursement SGB V, IQWiG, G-BA, GKV-SV, market access, RA & HTA, European developments Teaching time ca. 20 hours, Study paper ca. 20 hours	3
12	Regulatory Management / Decision Making Authorisation strategy, regulatory aspects and marketing Teaching time ca. 15 hours, Study paper ca. 15 hours	2