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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
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 ***
2019 Damian Kaminski The EU cosmetics regulation in comparison to medicinal products: Evaluation of a risk-based approach ***
2019 Dr. Eleni Karakasili Contained Use or Deliberate Release? - National regulatory requirements for clinical trials with gene therapy medicinal products containing or consisting of GMOs in Europe ***
2019 Franziska Köthe Reclassification of Insulin products from drugs under FDC Act to biologics under PHS Act after March 23, 2020 and its impact on product development related to CMC dossier contents also with regards to registration of "Follow-on" Insulins and comparison with other major markets
2019 Dr. Jens-Uwe Künstler Regulatory Considerations for Pre-filled Syringes in Clinical Development - an EU and US Perspective
2019 Dr. Sapuna Mary Kuriakose Opioid crisis in US - Describing the historical background and discussing the regulatory strategies to tackle the epidemic ***
2019 Zeineb Laghmani Referral under Article 31 of Directive 2001/83/EC: An example of vancomycin-containing medicinal products ***
2019 Dr. Tanja Lidy Drug shortages for supply-relevant medicinal products exemplified by vaccines - Notifications, reasons and effects ***
2019 Amelie Link Herausforderung Zusatznutzennachweis bei seltenen Treibermutationen - Nutzenbewertungsverfahren nach §35a SGB V zum NSCLC mit ALK- oder ROS1-Treibermutation (2012 bis 2018) ***
2019 Astrid Maeder-Jeske Antimicrobial Resistance - An analysis of the current situation with a special focus on policy approaches and regulations in the European Union, the United States and on the part of the WHO to prevent an escalation of the situation ***
  • Total: 970