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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
2009 Dr. Christa Pfleiderer Regulatory Requirements for Pharmaceuticals, Biotechnological Products, and Biosimilars in Latin America: Common Requirements and Differences
2009 Dr. Agnieszka Pietas Non-Clinical and Clinical Development of Advanced Therapy Medicinal Products (ATMPs)
2009 Dr. Marcus Riehl New provisions for the Regulation on Maximum Residue Limits ***
2009 Dr. Werner Schmidt Legal Status of Donor-Lymphocyte Infusions manufactured by transiently activated Memory T cells in the context of the European Regulatory Framework
2009 Dr. Olaf Stamm Pathogen safety concepts for Biopharmaceuticals
2009 Josephine Stiebler Maintaining compliance with GRP while changing the business process aiming to be able to submit new applications in electronic format (eCTD, paperless) appropriately by end of 2009
2009 Petra Sulzer Requirements for and assessments of medical devices utilising animal tissues and their derivatives ***
2009 Edith Ueberschaer Regulatory Requirements for Electronic Expedited Reporting in the European and in the German Legislation with Examples to their Implementation in a Pharmaceutical Company ***
2009 Dr. Rüdiger Vallon Regulatory framework for advanced therapy medicinal products (ATMPs) according to the Regulation (EC) No 1394/2007 ***
2009 Dr. Susanne Vambrie Regulatory Requirements for the Clinical Development of New Therapies for the Treatment of Alzheimer’s Disease ***
2009 Dr. Christina Veiel-Fietzek Addition of a manufacturing site for a sterile medicinal product (lyophilisate) - Points to consider for transfer of manufacturing process to a contract manufacturer and impact of changes with regard to the registration dossier in the light of the current variation procedure ***
2009 Dr. Corinna Weidt A regulatory guidance on achieving and maintaining proof of compliance with an agreed PIP ***
2008 Dr. Edda Ballweber In vitro equivalence criteria of orally inhaled products (OIPs) and role of in vitro data in the overall therapeutic equivalence program - A comparison between Europe, Canada and the U.S. ***
2008 Mariela Becker Experiences with the New Decentralised Procedure –Changes, Limits, Perspectives ***
2008 Rainer Brunschier Generic Drug Submissions in Japan from a Global Player’s Point of View ***
2008 Dr. Matthias Dormeyer Regulatory Strategies and Practical Aspects for the Development and Authorisation of Orphan Medicinal Products in the European Union ***
2008 Dr. Derk Eldert Görich One Step beyond the eCTD: Update of the Dossier by electronic Variations In Europe and Germany
2008 Dr. Andreas Grummann Strengthening and Rationalising the European Pharmacovigilance System ***
2008 Nadine Herzog Optimisation of Master File Procedures for Biologics: Comparison of Master File Procedures - EU and USA ***
2008 Dr. Monika Hitzl Global regulatory requirements and how to reflect them in the process control system of pharmaceutical industry - Implementation of Process Analytical Technology
  • Total: 720