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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 Dr. Nicole Wagner International Nonproprietary Names (INNs) - A Critical Issue For Biological Medicinal Products ***
2007 Dr. Michael Walser Analytical Method Validation: Compilation of Relevant Legislation, Guidelines, and Literature
2007 Johanna Walter, (geb. Bleicher) The new CMD(h) - a chance for reaching agreement in MRP and DCP? ***
2007 Martin Watzl The New Paediatric Regulation in the EU -– Development, Implications and Comparison with US Experiences in Paediatric Drug Development ***
2007 Tanja Weber A Step Beyond Module 3 of Biodegradable Implants ***
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 Anne Althoff Demarcation of Herbal Borderline Products – Medicinal Products or Food Supplements? ***
2006 Dr. Tatyana Benisheva-Dimitrova Challenges For The Pharmaceutical Legislative Implementation In Terms Of An Accelerated Market Access After October 2005 ***
2006 Dr. Markus Beßeling European decentralised procedures for marketing authorisation –Differences and similarities between applications of veterinary and human medicinal products ***
2006 Dr. Reinhard Bogan Regulatory requirements for quality management systems in preclinical research and development with special emphasis on the principles of Good Laboratory Practice
2006 Dr. Ursula Bonsmann Biowaivers Based on the BCS –Only for Class I
2006 Thurid Buch, geb. Fassbender The (European) Public Assessment Report as an extended part of the European application procedure - Regulatory background and practical considerations
2006 Dr. Sabine Drechsler The re-evaluation regulatory assessment procedure for old herbal medicinal products in Germany, focussing on clinical aspects ***
2006 Monika Frei Parallel import of generic medicinal products - Possible impacts of the Kohlpharma Case ***
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 Claudia Hahne Angemessenheit der Regelungen zum Vertrieb von Medizinprodukten
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 Sylvaine Hartmann Change Control and Variations in Chemistry – Consequences on the regulatory workload for Active Substance Manufacturers ***
  • Total: 956