DE EN Anmelden

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

Downloads from A-Z

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

Send e-mail

Master's thesis

The collection of Master's theses can be searched and sorted by entering keywords.

Year Name Title Full text Summary
2016 Dr. Francois-Xavier Orveillon Status, challenges and regulatory framework for the development and registration of virus vectored vaccines in Europe
2016 Dr. Julian Paesler Contraception in adolescents - regulatory considerations ***
2016 Dr. Andrea Rohrauer-Scherr Benefit Assessment and Indication in Marketing Authorisation - Relevance for and Impact on Paediatric Research, Pricing, Reimbursement, Medical Therapy and Advertising ***
2016 Gianluca Ronzoni Technical Regulatory change assessments for worldwide approved medicinal products - complexities in a regulatory non-harmonized and dynamically evolving environment
2016 Ellen Scheibe The issue of extrapolation of indications in the registration of biosimilars ***
2016 Dr. Brita Schulze Different Salts of a Drug Substance - Comparison of Regulatory Pathways in the EU and USA ***
2016 Dr. Volker Spehr Virulence factor inhibition, a novel approach to treat life-threatening bacterial infections: Challenges for industry, legislation, and agencies ***
2016 Till Teschke Changes in the regulatory assessment of manufacturing process validation ***
2016 Anna Touhidi The Double Edged Regulation of Liquid Chemical Germicides Used in Healthcare Settings. The Burden of a Joint Jurisdiction, Demarcation of Categories and Regulatory Requirements in the United States of America ***
2016 Dr. Michael Türck Regulatory and Practical Consequences of the New Clinical Trial Regulation (EU) No 536/2014 for the Clinical Trial Application Processes of Pharmaceutical Companies and CROs ***
2016 Julia Vogel Assent - differences in Europe and potential for harmonization
2016 Cornelia Wagner Overview of the Active Substance Master File Approaches in the European Union, Japan, Brazil, Russia and the World Health Organization from the Perspective of an API Manufacturer of Small Molecules
2016 Svetlana Walter Dependencies between marketing authorisations in Developed and Emerging Markets – Implications for Regulatory Strategy ***
2016 Immanuel Weber New safety features against falsified medicines according to the Delegated Regulation (EU) 2016/161: Consequences for Parallel Distributors
2016 Dr. Ruth Zeller-Adam The European Council's Partial General Approach to the Proposal for a Medical Device Regulation: Its potential implications on demarcation, classification, and conformity assessment of substance-based medical devices ***
2016 Dr. Valeria Ziemann Overview of Regulatory Requirements for Marketing Authorisations of Pharmaceutical Products in Countries of Eurasian Economic Union
2016 Astrid Zimmermann Regulatory Requirements of Marketing Authorization Holder Transfers in International Markets
2016 Dr. Ina Zschocke Standard for Outcome Measures in Clinical Trials for the treatment of plaque psoriasis supporting Labelling Claim and their application in practice – a critical review of the EMA Guideline CHMP/EWP/2454/02corr and a proposal for future development ***
2015 Dr. Andrea Abele Skinny labelling ***
2015 Pablo Gabriel Amaya Rodriguez Pharmaceutical pricing and reimbursement in Latin America - Implications for Regulatory Strategy ***
  • Total: 959