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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
2013 Dr. Lars Möllmann New developments regarding regulatory requirements for stability testing in the European area
2013 Dr. Sonja Obermann Off-Label Use of Medicines – General Aspects, Challenges and Strategies ***
2013 Dr. Astrid Oelmann Definition and Establishment of the Regulatory Starting Material in the Synthesis of Chemical Pharmaceutical Drug Substances in Europe
2013 Dr. Claudia Osterhage Quality of APIs and Starting Materials used for the Manufacture of Medicinal Products in the EU Including Risks for Genotoxic Impurities
2013 Claudia Pönisch Medication errors and the European Pharmacovigilance legislation - specific focus on Biomedicines
2013 Verena Prusinovsky Medicinal Products for Nebulisation in Europe: Requirements, Challenges and Options ***
2013 Anna Sahl Relevance of a Certificate of Pharmaceutical Product for registration and Life Cycle Management of imported Drugs. How is the WHO Certification Scheme implemented by National Health Authorities outside of the ICH? ***
2013 Marcus Schade Conduct of Clinical Trials in Latin American Countries: Background, Regulatory Framework and Implementation of relevant EU Requirements ***
2013 Alexandra Scheibe geb. Kürzel Impact of the Implementation of Directive 2004/24/EC: Development of Marketing Authorisations for Herbal Medicinal Products and Registrations for Traditional Herbal Medicinal Products in Germany in the European Regulatory Environment ***
2013 Dr. Christiane Scherer How to define the acceptable evaluation threshold (AET) for large volume parenterals (LVPS): European regulatory requirements and their practical implementation outweighing patients` needs versus safety ***
2013 Dr. Marion Petra Schergaut Human Generic Drug Requirements in the APAC Region: Distinctions and Similarities Influencing the Development Strategy
2013 Dr. Karin Schleisiek The new role of excipients: Developments in the framework of GMP and the impact for the pharmaceutical industry
2013 Simon Schmidmeier Two years AMNOG and early benefit assessment pursuant to § 35a SGB V - a critical review from the manufacturer´s point of view
2013 Marlene Schulzensohn How to place human medical devices on the market? An overview and critical examination of the regulatory requirements in Germany versus those in the United States ***
2013 Dr. Verena Schummer Developments in anticancer immunotherapies for use in combination ***
2013 Dr. Christin Selent-Stier Development of an adequate strategy for a global change in the primary container closure system of a parenteral herbal drug ***
2013 Svenja Seyler-Junker Evaluation of design and layout of folding boxes of centrally approved medicinal products using a decision matrix developed from legal requirements and available guidance documents ***
2013 Dr. Amir Saeed Sheikholeslam Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System ***
2013 Dr. Sebastian Specht ICH - Strengths, Weaknesses and Future Tasks
2013 Beate Stadler Pharmacovigilance Referrals - Changes in line with the new Pharmacovigilance Legislation 2010 / 2012 ***
  • Total: 969