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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 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
2019 Dr. Alexandra Baumann The obese patient - regulatory framework and challenges for the development, approval and prescription of medicinal products used in overweight subjects with a focus on the European Union ***
2019 Dr. Veronika Bernek New challenges for medical device manufacturers: Implementation opportunities for post-market surveillance regarding the new MDR 745/2017 requirements for medical devices
2019 Andrea Brischle Voluntary post-authorisation studies: differentiation, regulatory requirements and value ***
2019 Lena Chugunow Innovative Immunotherapy in Oncology - PD-1 / PD-L1 Inhibitors in Treatment of Non-Small Cell Lung Cancer (NSCLC) and its Regulatory Aspects
2019 Genoveva Dimitrova Direct Healthcare Professional Communication (DHPC) als Teil der Risikokommunikation resultierend aus europäischen Verfahren und ihre nationale Umsetzung in Deutschland
2019 Dr. Abdelouahid El-Khattouti Generic Drugs: eCTD module 3 differences and similarities between US and Europe with a special focus on IV-drugs
2019 Dr. Anna Ernst The Nagoya Protocol - Background and impact on Pharmaceutical Industry ***
2019 Iris Fichert Today's regulatory strategies and clinical approaches for the development of treatment regimens for active MDR-TB
2019 Dr. Ornella Fumagalli Regulatory requirements for CAR-T Cell Therapy against cancer - a comparison between the EU and the US ***
2019 Moritz Hass The new aspects and changes of the Medical Device Regulation on classification of Medical devices with focus on software
2019 Nicole Hauptmann Interchangeability of biosimilars - comparison of EU and US perspective ***
2019 Mireille Hertel Mergers & Acquisitions - European Regulatory Affairs challenges to achieve a portfolio harmonization - a company perspective ***
2019 Dr. Bastian Hoffmann In the Area of Tension between the Conditional Marketing Authorization and the Health Technology Assessment: Challenges for the Pharmaceutical Industry
2019 Dr. Katharina Holl BCS-based biowaivers in the context of ICH M9 and its implications on the pharmaceutical industry ***
2019 Tobias Hyneck Verschreibung und Abgabe von Betäubungsmitteln in Deutschland, Österreich und der Schweiz ***
  • Total: 959