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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, diverse and the results are both of interest in a scientific context and relevant to many areas of activity in 'Drug Regulatory Affairs'.

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

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

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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
2010 Dr. Erik Schneider Determination and comparison of the regulatory requirements of human recombinant antibodies, Fab-fragments and aptamers regarding product and manufacturing quality
2010 Anna Volodina Clinical Studies in Eastern Europe: critical assessment of the regulatory requirements ***
2010 Dr. Claudia Karin Wagner Distribution restrictions (Re-switch of OTC medicines) in Germany and in other selected countries ***
2010 Sabine Wolf European and German Regulatory Requirements to the Design and Validation of Nucleic Acid Tests for Blood Screening ***
2010 Dr. Karl Zimmermann Die gewerblichen Schutzrechte bei Arzneimitteln in der Europäischen Union und den USA – Arzneimittel und Patente
2010 Michael Zlottchenko The Quality and Safety Requirements for Vaccines with Emphasis on Viral Vaccines from a Global Point of View
2009 Stephan Becker Regulatory Considerations on Drug Interaction Studies ***
2009 Dr. Claus-Peter Danzer Borderline Situations and other important Aspects for the Regulatory Work with Medicinal Products for Oral Care in Europe
2009 Dr. Ulrich Feil Replacement, Reduction, Refinement of Animal Testing in Quality Control of Medicinal Products in the EU ***
2009 Sabina Freund-Rieger Market Exclusivity versus Market Penetration: Theory and Practice of Originator –Generic Competition ***
2009 Michael Hahn Die Auswirkungen der Arzneimittelrabattverträge nach dem GKV-Wettbewerbsstärkungsgesetz auf den deutschen Generikamarkt
2009 Dr. Frauke Hätzelt Vitamins as Medicinal Products – Regulatory Considerations ***
2009 Dr. Thorsten Henning Rx-to-OTC switch – Comparison of the Current Regulatory Approaches in Germany, in the UK, and in the USA ***
2009 Viola Hieble-Gerhard Risk-based management of GMP audits within the context of supplier relationships – an approach for a medium-sized pharmaceutical company ***
2009 Dr. Angelika Hönlinger Referral procedures – Overview, analysis and outlook ***
2009 Christine Kriete Peculiarities and Challenges of Herbal Medicinal Products -
Assessment of Herbal Medicinal Products within the Regulatory Environments of the European Community and the United States ***
2009 Dr. Susanne Manhart Development of a New Active Substance for Treatment of Alzheimer’s Disease – Development from Preclinical Testing to Proof-of-Concept ***
2009 Dr. Nicole Max Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines – a controversial discussion ***
2009 Dr. Stephanie Mondabon The European Commission’s "Pharmaceutical Package": An Analysis ***
2009 Dr. Christel Neiteler Classification Issues on the Borderline between Medical Devices and Medicinal Products –- Review of the Current Regulatory Discussions and Decisions ***
  • Total: 720