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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 Heike Trautmann Regulation (EU) 2015/2283 on novel foods - Analysis of the amendments and their impact on regulatory work ***
2019 Dr. Anja von Au Medical device safety reporting in clinical investigations and PMCF studies under the new MDR - A comparison to the current German legislation
2019 Dr. Oliver Walisko Potency Assignment of Factor IX Medicinal Products for the Treatment of Hemophilia B: Regulatory meets Practice ***
2019 Susanne Werk The European MDR and its potential impact on the existing German legislation on medical devices and the status of the discussion on the interpretation of several requirements of the MDR
2019 Fabian Witzel Standardization as Key for Global Digital Health Regulatory Affairs Improvement ***
2019 Dr. Nicole Woik Comparative analysis of the strategies for implementation of the Clinical Trials Regulation (EU) No 536/2014 in Europe ***
2019 Dr. Daniel Zucker Implementation of Regulatory Requirements for Lipid based Excipients - Claims and Reality
2018 Carlos Canete Bacteriophage therapy: an analysis of the European regulatory framework and its proposals for amendment ***
2018 Lais da Silva Critical Assessment - Implementation of ICH Guidelines in Brazil ***
2018 Sofia Dust Impact of China's regulatory reforms on business operations in Chinese pharmaceutical market: Perspectives and Challenges for multinational pharmaceutical companies ***
2018 Zohaira El Malahi Maintenance of Marketing Authorizations of Medicinal Products in the MENA Region – Differences and Similarities to European Procedures ***
2018 Sebastian Fischer The 2017 EC Report on the Paediatric Regulation - A critical analysis of stakeholder positions ***
2018 Dr. Maxim Frizler GVP module V revision 2 a review of recommendations and main changes
2018 Dr. Karin Geßele Regulatory Framework and Challenges for Approval of "Generic" Non-biological Complex Drugs (NBCDs) ***
2018 Mareike Gleissner New Legal Framework for Food for Special Medical Purposes - Implications on Demarcation and Regulatory Requirements at European Level and in Germany ***
2018 Dr. Florian Haberl IDMP - a business driver for implementation of a company wide master data management system in pharmaceutical companies
2018 Hannah Hähl Adaptive Pathways - Challenges of a global development program for early patient access in the context of the current Health Care System and Health Technology Assessment Landscape in Europe, USA and Japan
2018 Dr. Susan Heller Harmonisation of quality dossier following Union Referral - Challenges and points to consider with focus on sterile finished products ***
2018 Dr. Claudia Heß Expectations of eCTD 4.0 - also a step forward for small and medium sized enterprises? ***
2018 Sylvia Hinderfeld Labelling Requirements for Clinical Trials in the EU - Overview of current and future requirements when Regulation (EU) 536/2014 applies ***
  • Total: 959