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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
2017 Dr. Eva Skerhutt Making an old biologic great again - a regulatory survey about new indications for an old product and their requirements
2017 Doreen Stoof The Republic of Serbia on its way into the European Union? Review of regulatory preparation, discussion of challenges and future prospects for registration procedures of medicinal products
2017 Dr. Christian Strube Challenges and Considerations in Developing a Regulatory Compliance Department in a Medium-sized German Pharmaceutical Company ***
2017 Dr. Nadine Temme Delivery of nucleic acids mediated by engineered protein nanoparticles - Preclinical development from a regulatory point of view
2017 Dr. Christina Wallkötter Referral procedures of Directive 2001/82/EC - General principles, analysis of Article 78 procedures and future outlook
2017 Anna Wehage Brexit: Possible regulatory impacts on the pharmaceutical industry and marketing authorisation holders in Europe ***
2017 Birte Weselmann International cooperation among Drug Regulatory Authorities
2017 Anja Wiechmann Post-Approval Change Management Systems in the ICH Region with Focus on "Established Conditions" ***
2017 Barbara Wiglinghoff Medication errors - new challenges for pharmaceutical industry, authorities and health care professionals including the guides "EMA/762563/2014" and "EMA/606103/2014" and selected drug therapy safety projects ***
2017 Dr. Yan Xu The impacts of EudraVigilance enhancement on signal detection - from the perspective of pharmaceutical industry ***
2017 Andre Zernov Regulation of the pharmaceutical market in the EAEU, Russia and Ukraine: Similarities and differences
2016 Silvia Balogh Extensions of indication in the European Union - a regulatory overview ***
2016 Dr. Dagmar Behnke Implementing the new Pharmacovigilance legislation - challenges for the pharmaceutical industry ***
2016 Dr. Mayte Bewersdorff Biosimilars in the U.S. - the long way to their first approval ***
2016 Manuel Bilke EMA Clinical Data Transparency: A Critical Synopsis ***
2016 Dr. Stefanie Blättermann Structured Product Labeling standard: A tool for IDMP implementation and electronic package leaflet creation?
2016 Dr. Iris Bruchmüller Cannabis for medicinal and recreational purposes and new psychoactive substances – Critical review of recent legal initiatives in Germany ***
2016 Dr. Sarah Büchner Coping with Drug Shortages through regulatory governance: Approaches and perspectives to a complex global challenge ***
2016 Dr. Henrietta Dehmlow eCTD submissions - a global reality already? ***
2016 Dr. Konstanze Eisfeld PRIority MEdicines (PRIME) – a scheme by the EMA to accelerate the development of medicines that target an unmet medical need
  • Total: 959