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In your studies 'Drug Regulator Affairs'

©Volker Lannert / Universität Bonn

Master's thesis


As part of the continuing education Master's degree programme, Master's theses are written on relevant topics in the field of 'Drug Regulatory Affairs' using scientific methods. The topics are highly topical, various and the results are both of interest in a scientific context and relevant to many areas of activity in 'Drug Regulatory Affairs'.

Below you will find all Master's theses written since the year 2000, including author, title and summary. In this collection, many Master's theses can also be viewed and downloaded in full text.

Award-winning Master's theses from our programme can be viewed here (DGRA Award and DGRA Study Award).

Further information on Master's theses (e.g. registration, processing) can be found in our ‘Master's thesis guidelines/Leitfaden für die Anfertigung einer Masterarbeit’ (in German) and in the ‘Information leaflet - Master's thesis’ at

Downloads from A-Z

Do you have any questions or are you interested in the full text of a Master's thesis that is not listed here?
Please feel free to contact me.

Dr. Jasmin Fahnenstich

Dr. Jasmin Fahnenstich

Study programme manager

Phone: +49 (0) 228 - 9268 6806

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Master's thesis

The collection of Master's theses can be searched and sorted by entering keywords.

Year Name Title Full text Summary
2005 Hiu Wah Yuen Implementing CMC Section of the Clinical Trial Directive
2004 Dr. Christine Binninger Regulatory standards on clinical trials for medical devices and medicinal products in case of orthopedically used hyaluronic acid
2004 Lada Bogdanovic Implications of the EU Clinical Trial Directive 2001/20/EC on the conduct of paediatric studies in Germany
2004 Dr. Franz-Josef Braun The Legal Framework for Parallel Trade in Pharmaceuticals for Human Use in the European Economic Area
2004 Dr. Ingeborg Cebulla Changes to biological medicinal products (Case Study: Vaccines)
2004 Dr. Ulrike Domack Regulatory Science on Orphan Drug Application within Paediatric Field
2004 Dr. med. Klaus Eckhardt Clinical development of a new chemical entity compared to a somatic cell therapy product for Parkinson´s disease in the regulatory framework of the EU
2004 Dr. Angelika Freund "Regulations Concerning "Off-Label-Use" of Medicinal Products in Germany"
2004 Dr. Doreen Gerlach The "Arzneimittel-TSE-Verordnung" in Germany - Motives for this regulation and its consequences for medicinal products containing gelatine
2004 Britta Ginnow Impact of the new Variation Regulations 1084/2003 and 1085/2003 on the industrial practice of a multinationally operating pharmaceutical company with regard to the EU enlargement and the multinational procedure in performing variations
2004 Dr. Beate Golba Market Surveillance of Medical Devices in Germany and Europe
2004 Dr. Daniel Gommel Developments in Regulatory Pharmaceutical Toxicology:
2004 Dr. Gisela Greger Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products
2004 Dr. Ulrike Greger Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland
2004 Dr. Heribert Halex Regulatory Aspects of Stability Testing of vaccines representative of Biological Medicinal Products
2004 Claudia Hettenkofer Implementation of an internal Standard Operating Procedure for the Preparation of Mutual Recognition Variations
2004 Dr. Petra Heyen Regulatory Intelligence as the basis for Regulatory Strategy and Global Drug Development
2004 Anja Hilse Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing for blister packs
2004 Dr. Thomas Lauterbach Characterization of Impurities during Development of Chemically Synthesized Compounds Regulatory Requirements
2004 Jiqing Madeleine-Wang A Comparison of Generic Submission in Europe and in Asian Countries
  • Total: 979