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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

Downloads from A-Z

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
2021 Dr. Manja Burggraf "Lessons learned" for Regulatory and Scientific Advice of Vaccines and Biologicals in Times of COVID-19
2021 Dr. Xia Dong Regulatory Framework and Key Steps of Medical Device Registration in China under Current and Revised Regulations on Supervision and Management of Medical Devices ***
2021 Alexandra Federer Digitalization: Challenges and opportunities for the pharmaceutical industry with regard to advertisement and trade (digital shelfs) ***
2021 Francesca Haaf The antiviral remdesivir - an example of expedited approval procedures in the USA within the Covid-19 pandemic ***
2021 Corinna Herkenhoff Rezepturarzneimittel in Deutschland: Rezeptur- und Fertigarzneimittel im Vergleich. Ist die Herstellung nach ApBetrO noch zeitgemäß? ***
2021 Kristina Hoffmann Electronic product information - The global status quo and possible ePI advancements in the EU
2021 Johannes Korward Dry Eye Disease: Regulatory Requirements Differ Around the Globe – with Implications for Product Development and Patient Access. A review of standards for new ophthalmic therapies in key pharmaceutical markets. ***
2021 Dr. Karin Kroboth A Comparative Analysis of Antibody Drug Conjugates in Europe and the US
2021 Julia Leuthner PUMA-Arzneimittel in der Nutzenbewertung nach § 35a SGB V (2014-2019)
2021 Theresa Löschmann The Company Core Patient Information (CCPI) - a useful tool for regulatory compliance?
2021 Katarzyna Makosch Worksharing procedure - what’s the point? An overview about worksharing procedure as regulatory tool
2021 Dr. Sarah Matheisl Quality-related Challenges of Viral Vector-based Gene Therapy ***
2021 Marieke Ostwald (geb. Dölz) Herausforderungen eines pharmazeutischen Unternehmers durch verschiedene internationale Fälschungsschutz-Systeme ***
2021 Barbara Petzold Accelerated Development of COVID-19 Vaccines: Clinical Data Gaps Identified by Health Authorities and Respective Post-Authorisation Activities ***
2021 Anna Rubik Drug Shortage - A complex global challenge. Recent developments in the EU, industrial aspects with a special focus on Austria and an idea of international handling via a global portal ***
2021 Dr. Alex Savtschenko Preclinical toxicity profiles of authorised medicinal products: analysis and comparison between short-term and long-term repeated dose toxicity studies in animals ***
2021 Dr. Ramsi Siaj The New ICH-Guideline S11 on Nonclinical Safety Testing - Opportunities and Challenges for Overall Development of Paediatric Medicine ***
2021 Dr. David Thalmann New Dosage Forms of Old Substances - Regulatory Strategies and Challenges in the European Union ***
2021 Dr. Sara Tognarelli Between flexibility and standardization: the challenge of the first European Pharmacopoeia individual monograph for monoclonal antibodies. The case study of the monograph 2928 "Infliximab concentrated solution"
2021 Sandra Walkowiak Fast and Simplified Procedures for Herbal Medicinal Products in Pacific Alliance Countries
  • Total: 961