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STUDY MODULES

Appendix 1 to Article 4, Section 2 of the Examination Regulations for the continuing education course ï¿½Master of Drug Regulator Affairsï¿½

Information on the study modules can be obtained by clicking on the course titles.

No		Module

1		Definition and description of the functions of Drug Regulatory Affairs, Good Regulatory Practices attendance approx. 30 h, course work approx. 30 h, credit points: 5

2		Pharmaceutical Law Drug law in Germany, the EU and other countries and related laws attendance approx. 30 h, course work approx. 30 h, credit points: 6

3		International marketing authorisation procedures Principles and procedures of the marketing authorisation for medicinal products, diagnostics and medical devices in the EU, USA, Japan and worldwide attendance approx. 45 h, course work approx. 30 h, credit points: 7

4		General aspects of Module 1 (CTD) and authorisation of specific medicines Varying standards in registration procedures for single agent and combination preparations, drugs for special therapeutic applications and veterinary drugs; aspects of distribution in Germany and post-authorisation procedures attendance approx. 30 h, course work approx. 30 h, credit points: 5

5		Maintenance of marketing authorisations / pharmacovigilance Application-associated monitoring, marketing, variations, renewals attendance approx. 30 h, course work approx. 30 h, credit points: 6

6		Information management, eCTD From literature research via processing of documents and data to assessment of information and electronic submission attendance approx. 20 h, course work approx. 20 h, credit points: 3

7		Quality management / medical devices Good practice rules, international standards, quality management and control; medical devices legislation attendance approx. 30 h, course work approx. 30 h, credit points: 5

8		Chemical-pharmaceutical documentation Documentation from synthesis via analytics, pharmacopoeia monographs to form of adminstration and production attendance approx. 30 h, course work approx. 30 h, credit points: 6

9		Pharmacological-toxicological documentation Documentation of pharmacology, toxicology, genotoxicity and ecotoxicology attendance approx. 30 h, course work approx. 30 h, credit points: 6

10		Clinical documentation Documentation of clinical investigations on humans, clinical trials, case studies and reports on drug use attendance approx. 30 h, course work approx. 30 h, credit points: 6

11		Pharmacoeconomics / Health policy Cost-benefit ratio, pricing policy, methods of cost savings attendance approx. 20 h, course work approx. 20 h, credit points: 3

12		Decision analytics Marketing authorisation strategies, regulatory aspects, marketing strategies attendance approx. 15 h, course work approx. 15 h, credit points: 2

		Detailed information on the contents of the modules is given in the annual Study Plan. Regulations based on German law are presented in German, those based on European or non-European law in English.