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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
2022 Spyros-Dimitrios Roussos The Marketing Authorization transfer in the LATAM countries - Brazil, Mexico, Argentina, Colombia, Chile, Peru (major LATAM economies) and Panama, Guatemala, Costa Rica (SICA countries) & Venezuela
2022 Dr. Niklas Schaumann Supporting IDMP implementation through AI-based data extraction - An explorative approach ***
2022 Dr. Vivian Scheuplein Nonclinic for TCR-transgenic T cells for adoptive T cell therapy of cancer - current requirements for applicants to EMA and FDA
2022 Yuan Shi "State-of-the-art" in new EU medical device regulations: a review of its development in medical device law, the interpretations from stakeholders, impacts, and possible solutions for implementation ***
2022 Anna Sobek Safety Labelling Implementation - a Challenge for Marketing Authorisation Holders and an Opportunity through ePI to increase Patient Safety ***
2022 Dr. Daniel Sohmen Approval options of therapeutics for treatment of the Coronavirus disease 2019 and their current regulatory environment ***
2022 Dr. Nico Steiert Entwicklung von "skinny labelling": eine Betrachtung aus der regulatorischen und Patentperspektive ***
2022 Dr. Sabrina Stöhr State-of-the-Art Reporting of Clinical Trial Results - Suitability of ICH E3 in a Changing Regulatory Landscape ***
2022 Dr. Birthe Inken Sumpf Verordnung (EU) 2019/6 für Tierarzneimittel - Allgemeine Zielsetzung der Verordnung mit Fokus auf die Antibiotikaresistenzproblematik und die Verschreibungskaskade ***
2022 Dr. Carina Tirler A review of regulatory drivers and anticipated changes to be adopted by 2025
2022 Isabel Valentin Verdeguer Rare diseases and market access to orphan drugs - analysis of the related legislation in the region of LATAM from a comparative perspective with Europe and USA
2022 Dr. Marian Wiegand Regulatory-conform development of mucosal vaccines with a focus on quality, nonclinical and clinical aspects
2021 Dr. Ilona Ahonen Sex hormones and their antagonists: unmet medical needs in rare and paediatric diseases
2021 Bilal Alyousef Regulatory Affairs in the Gulf Cooperation Council Region
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.
  • Total: 961