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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
2012 Sylvia Streit Impact of the new Pharmacovigilance legislation on national level
2012 Ellen Thom Case study: EYLEA® - A new drug from Bayer Healthcare and pricing under the conditions of AMNOG
2012 Carolin Wedel Global Development Strategy for Generic Medicinal Products with Regard to Bioequivalence Studies - Special Focus on the Biowaiver Approach in Canada, Australia and Brazil ***
2012 Dr. Markus Weidlich ICH Q11 - Potential Regulatory Implications for the Development and Manufacture of Synthetic Drug Substances Using an Enhanced Approach ***
2012 Hella Witt Should the European Union introduce 'nutrivigilance' for food supplements and dietary foods for special medical purposes?
2011 Klaus Albrecht PKPD-modelling from a regulatory affairs perspective
2011 Dr. Andrea Aschenbrenner Registration of Herbal Teas as Traditional Herbal Medicinal Products according to §§39a-d AMG ***
2011 Dr. Monika Unha Baik Stability Testing in the four climatic zones - Purpose, History, and Requirements
2011 Judith Beer 4th Amendment of the Medical Devices Act: First experience with the new application procedure for clinical trials exemplified by an EU-funded multinational trial
2011 Sophie Breitenfeld, geb. Brenner Central Registration in the Gulf Countries – An Opportunity for Global Companies?
2011 Dr. Henning Brohmann Genotoxicity in mammalian cell assays in vitro: necessity to revise current pharmaceutical regulations? ***
2011 Dr. Carolina Cassara Adjuvants in Human Vaccines ***
2011 Dr. Tom Deutschle Regulatory assessment time for purely national variation and renewal applications in the Nordic Countries - a retrospective data analysis
2011 Dr. André Dorochevsky EMA's Product Information Management (PIM) project halted – Impact from the perspective of biotech companies on strategies for structured product information management ***
2011 Antje Ebermaier Continuous update of antimicrobial resistance data of purely nationally authorised antibiotics for human use in Germany - a challenge for European registrations
2011 Dr. Thorsten Externbrink Generic In-licensing - Points to Consider, Regulatory Aspects and Interdependencies ***
2011 Ines Feile Requirements on the chemical-pharmaceutical documentation for homeopathic and anthroposophic medicinal products of herbal origin - a critial evaluation
2011 Dr. Frank Förster Development of Alternative Carcinogenicity Test Methods in the Pharmaceutical Industry: Evaluation of the Current Validation/Application Status ***
2011 Sabine Franke How harmonised are Drug Regulations and Regulatory Decisions in EU and US? Expectation and Reality ***
2011 Girmay Gebremedhin The Role of Microbiological Test Methods in Enhancing the Availability and Ensuring the Safety of Pharmaceuticals for Human Use
  • Total: 969