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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
2012 Dr. Holger Berk The legislative framework for veterinary medicinal products in Europe under revision - A review on primary objectives, key issues, policy options and their impact assessment
2012 Prof. Dr. Dr. Thomas Bieber Stratified medicine: A new challenge for the academia, industry, regulators and patients ***
2012 Christian Biegel EudraVigilance Medicinal Product Dictionary - a challenge for authorities and marketing authorisation holders
2012 Jürgen Blömer User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe
2012 Nicole Dévaud Veterinary medicinal products authorised for rabbits in the European Union - Causes for insufficient availability and consequences on human and animal health ***
2012 Dr. Axel Dienemann Pharmaceutical development of medicines for paediatric use - requirements, challenges and implications
2012 Dr. Sven Enders Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts
2012 Stephanie Gelsen Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline
2012 Dr. Astrid Gerhardt Exceptional Japan filing of a biologic mature product
2012 Christian Hanke Project-, Drug-, and Business Development in a Biotech SME ***
2012 Ulrich Härtel Clinical trial standard protocols, approaches for more regulatory efficiency? ***
2012 Dr. Martin M. Hartge HTA of orphan oncological medicinal products - A current critical assessment and discussion from authority, KOL and industry point of view
2012 Pia Helfrich Investigator-Initiated Trials on Medical Devices - Legal Basis and Regulatory Aspects ***
2012 Dr. Leonie Hempel Challenges and Chances of the Development of Biosimilar Monoclonal Antibodies in the EU
2012 Dr. Matthias Hübner Worldwide Regulatory Strategy for the Development and Submission of a Recombinant Product antagonizing the Action of a Medicinal Product ***
2012 Dr. Viktor Ivandic Methodological Requirements for Early Benefit Assessment in Germany (G-BA/ IQWIG) and Single Technology Appraisal in England (NICE) - a Comparison ***
2012 Angelika Kamp 2 years Variation Regulation: A retrospective critical assessment from the industrial perspective ***
2012 Karen Koch An Overview of the Orphan Drug Status which has been put in place in countries in order to stimulate the research and development of treatments of rare diseases
2012 Martina Krüger Haberkamp Das Qualitätsmanagement im Blutspendewesen am Beispiel des Blutspendedienstes der Bundeswehr
2012 Judith Leyendecker Identification of Commercially Confidential Information and Protection of Personal Data - New transparency guidance (1st publication: June 2011) of EMA and HMA especially from the point of view of service companies
  • Total: 959