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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
2007 Martin Watzl The New Paediatric Regulation in the EU -– Development, Implications and Comparison with US Experiences in Paediatric Drug Development ***
2007 Dr. Tong Zhang Audit Check List for Sterile Active Pharmaceutical Ingredients
2007 Dr. Stefan Zwilling Monoclonal antibodies developed as anticancer drugs: EU clinical trial application with focus on IMPD requirements ***
2006 Dr. Ursula Bonsmann Biowaivers Based on the BCS –Only for Class I
2006 Dr. Hans-Joachim Gamperl Drug Risk Management from an Industry Perspective - a Task for the Life Time of a Medicinal Product ***
2006 Ellen Güttler Extended Role of Scientific Advice as a Consequence of the New Medicines Legislation in the EU including a Comparison to the Situation in the USA ***
2006 Dr. Maria Hambrügge Effective drug regulation as a promoter for access to medicinal products in developing countries – New initiatives within the legal framework in the EU and regulatory activities by WHO and regional regulatory harmonisation initiatives ***
2006 Dr. Katrin Jahn Zulassung und Handel von Produkten der traditionellen chinesischen Medizin (TCM) in der Schweiz und in Europa unter besonderer Berücksichtigung von Österreich und Deutschland ***
2006 Dr. Sibylle Kaiser Tissue engineered products – Need and requirements for an appropriate harmonised EU regulatory framework ***
2006 Dr. Cortina Kaletta Overview of the Regulatory Environment for Developing New Vaccines Including the Specific Smallpox Vaccine and Pandemic Influenza Virus Vaccines ***
2006 Dr. Angelika Koch Möglichkeiten und Grenzen der Vermarktung von pflanzlichen Produkten
2006 Dr. Manfred Kurz Registration of antibody based medicinal products ***
2006 Dr. Katrin Mayer Maintenance / life cycle management of a MRP-product – A case study ***
2006 Dr. Roger Müller-Pfaff Einführung des Hämaphereseverfahrens in den Blutspendedienst der Bundeswehr ***
2006 Gabriele Schäfer Regulatory assessment of registration processes for biosimilar products- Conditions to be fulfilled to use special registration procedures designed by different decision matrices ***
2006 Dr. Astrid Weyermann Labelling requirements for investigational medicinal products in multinational studies: bureaucratic cost driver or added value? ***
2006 Renzo Wolbold The regulatory environment and requirements for biological and biotechnology-derived medicinal products in Japan
2005 Katrin Dürr Comparison of marketing authorisations procedures for biotechnological products in the European Union and in Switzerland ***
2005 Dr. Susanne Gluding Chemical and Toxicological Qualification of Plastic Packaging Materials for Sterile Solutions ***
2005 Dr. Rudolf Gmeinbauer Decentralised Procedure, Mutual Recognition Procedure and Readability of SPC, PL, Labelling
  • Total: 720