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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
2011 Dr. Alexander Vuia First revision of the "Guideline on the Investigation of bioequivalence": BCS-based Biowaiver - opportunities and limitations
2011 Dr. Bettina Walter-Lorenzen Improvement of the workflow, quality and effective management of product information texts using a new database
2011 Dr. Günter Waxenecker The "Risk Based Approach" - an important tool for managing all the duties in Drug Regulatory Affairs
2011 Katrin Wengenroth Regulatory Challenges Due to Globalisation of Drug Development and Manufacture Focusing on the Quality of Medicinal Products
2011 Dr. Christian Wrehlke Development of a database concept for tracking and maintaining regional/country specific Product Information (PI) and PI requirements
2011 Frauke Zeller, (geb. Tuchalski) Development of a new medicinal product containing a NCE intended for global marketing taking national regulations and requirements in the MENA region into consideration
2010 Sigrun Adrian Die Entwicklung unterschiedlicher Rechtsvorschriften und deren Überwachung im Bereich der Sicherheit von Arzneimitteln und Medizinprodukten in Deutschland (Pharmako- und Medizinproduktevigilanz)
2010 Stanislaus Awrutski Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, the Ukraine and Belarus
2010 Dr. med. Maria Ida Behrens Chances for children with rare diseases under the Regulation EC 1901/2006
2010 Viktoria Behse Current experience with PIP approvals
2010 Dr. Anne Benzinger Regulatory requirements for preclinical development of bispecific antibodies
2010 Hanna Bölke Harmonisation of Product Information Texts of Generic Medicinal Products in EU – And its Impact on the Necessity of User Testing and Bridging
2010 Romuald Braun White Spots in Document Management in the Life Sciences Industry
2010 Dr. Dieter Brazel Regulatory Life Cycle Management of Plasma Protein Therapeutics
2010 Dr. Nadine Corvey Transparency of authorities – opportunities and restrictions
2010 Dr. Jasmin Fahnenstich Prescription of Cannabis - Regulatory environment and current situation in Germany in comparison with the Netherlands and the USA
2010 Andreas Försch Biomarkers in preclinical and clinical research: definitions, identification, applications, validation and qualification processes at the FDA and EMA
2010 Dr. Sabine Frenzen Regulatory Requirements for Biocidal Products in Comparison to Medicinal Products within the EU
2010 Dr. Anita Friedrich Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use Authorised via the Centralised Procedure (1995 –- 2009)
2010 Lars-Peter Frohn Measures for industry, government and public authorities in Europe in the combat against counterfeit medicines. What is being done and what can yet be done.
  • Total: 982