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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
2020 Anna Magg Does the SSCP bring the desired transparency for the European patients and the general public - Critical Assessment from an industry perspective
2020 Dr. Sonja Matt Regulatory considerations for the development of next generation antibody-based therapeutics: Historical overview and quality requirements in the EU ***
2020 Dr. Daniela Matthey-Inführ The new guideline ICH Q12 and its application to the production transfer of European approved and approvable medicinal products to a new manufacturing site - Does it provide any new benefits for the regulatory strategy? ***
2020 Monique Mendel-Ott The impact of changing legislation on the development, marketing authorisation and commercialization of medicinal products ***
2020 Mariam Motamen Simplification Instead of Complication: A Critical Assessment of Pharmacovigilance Legislation from an Industry Perspective ***
2020 Dr. Christina Nöcker Implementation of TPO IV in Switzerland - implications for regulatory strategies and comparison with the European legislation ***
2020 Kateryna Popova Normative Documentation in CIS region. Challenges for an EU Marketing Authorization Holder ***
2020 Dr. Inga Reimer ASMF Worksharing Procedure - Challenges and Advantages
2020 Dr. Jasmin Rickmeyer Impact of the Covid-19 pandemic on the management and conduct of ongoing clinical trials with medicinal products ***
2020 Dr. Ann-Kathrin Ridder Interface Pharmacovigilance and Regulatory Affairs; Establishment of a continous IT-process for implemention of pharmacovigilance procedures ***
2020 Dr. Ekaterine Schäfer Evaluation of Non-clinical Requirements for Medicinal Products containing Monoclonal Antibodies as an Active Substance based on review of EPARS during last 10 years (2010-2019) ***
2020 Dr. Kendra Schafti New challenges in biosimilar development in the context of current regulatory guidance ***
2020 Dr. Sabine Schürmann The labelling of excipients relevant to food allergies or food intolerances in the product information for medicinal products for human use in the EU ***
2020 PD Dr. Ganna Staal (geb. Kalayda) History of platinum-based drugs from a regulatory perspective ***
2020 Olguta Stanescu Considerations on regulatory requirements for registration of drug-device combination products in Canada and the European Union ***
2020 Kathrin Sugg Assessment of the Quality Part of a Finished Product Dossier of old products - Typical gaps, possible root causes, consequences of gaps ***
2020 Anna von Medem Vor- und Nachteile der europäischen Implementierung über SPOR anhand des Anwendungsbeispiels der eSubmission ***
2020 Dr. Felicitas Wendling Regulatory Considerations regarding Multilingual Labelling in the EU
2020 Dr. Hilke Zander Regulatory requirements for histology independent indications in oncology ***
2019 Kristina Baitinger Application for Marketing Authorisation for a Generic Medicinal Product in Germany and Canada - Comparative presentation of content in Module 3 considering the country specific Regulatory Requirements
  • Total: 720