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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
2021 Rumyana Atanasova CMDh-Project for Harmonisation of RMPs (HaRP): Aims and results - Survey analysis of the project for risk management plan (HaRP) harmonization ***
2021 Dr. Katrin Bäsell Coronavirus Pandemic (COVID -19) - Influence on Pharma Industry and Competent Regulatory Authorities and corresponding strategies/actions to deal with the situation
2021 Dr. Claudia Benz Implementation and Maintenance of additional Risk Minimisation Measures (aRMM) and their interdisciplinary challenges on a local level in a global company ***
2021 André Bick Gesetzgebung und Maßnahmen zum Fälschungsschutz bei Arzneimitteln in der Europäischen Union, den USA und Brasilien - ein Vergleich aus behördlicher Sicht unter besonderer Berücksichtigung der Serialisierungsvorhaben ***
2021 Dr. Maria Cristina Bolanos Vasquez Exceptional regulatory provisions governing vaccine development and approval in a pandemic situation - a model for the regulatory future
2021 Dr. Kim Burgard Sufficient clinical evidence under MDR for legacy devices and new products. Requirements and challenges before and after CE marking.
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 ***
  • Total: 967