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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
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
2011 Elke Gurschke Best Practice Guide for Regulatory Affairs in a German CRO - From Application to Clinical Trial Report: Implications of Well-Structured Completion of Relevant Steps ***
2011 Christian Heringer Regulatory requirements for the sterilization of medical devices
2011 Dr. Kirsten Jacobs Regulatory Requirements for medical devices in major countries of Latin America
2011 Susanne Junker, geb. Weber Preparation of a meaningful and appropriate risk management plan a multifunctional task ***
2011 Kristiane Kempny Approval of a biological medicinal product within the Mutual Recognition Procedure (RMS: Germany) - regulatory strategies and potential challenges from a consulting company's point of view with regard to current pharmaceutical legislation ***
2011 Silke Dorothea Kilzer Development of the Counterfeit Directive - More confidence in the legal supply chain? (Focussed on "Basic Requirements for Active Substances used as Starting Materials": ICH Q7, GMP) ***
2011 Dr. Dorothee Klinkowski Implications of the German Regulation on Therapy Allergens ("Therapieallergene-Verordnung") on the allergen manufacturing industry
2011 Christophe Klumb Making cellular therapies available to patients - Possible regulatory pathways in Europe and Germany ***
2011 Stefanie Lauhoff Die Überarbeitung der Packungsgrößenverordnung im Rahmen des AMNOG und deren praktische Auswirkungen ***
2011 Dr. René Leubert The Design Flexibility in Monographs for Excipients
  • Total: 959