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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
2015 Ute Worringen The Humanitarian Device Exemption of the United States as a Pioneering Concept in Orphan Device Regulation and its Implications for the Policy of the Regulation of Medical Devices for Small Populations in the European Union ***
2014 Noel Bettinville Current CMC Variation Regulation, change-control, and compliance - outline of a proposed CMC change implementation risk assessment & planning concept that embraces regulatory premises, supply chain forecasting, and quality systems
2014 Christian Döring Regulatory burden, adequate to Allergen Specific Immunotherapy? ***
2014 Dr. Alexandra Eckhoff Pharmacogenomic data in the product information of medicinal products ***
2014 Claudia Engeler-Plischka Sunscreen products - drug or cosmetics? A Comparison of the legal requirements for sunscreen products in Europe, Australia and United States ***
2014 Heike Fell Adaptive Design Clinical Trials ***
2014 Dr. Monika Fürlinger A risk benefit analysis of Biosimilars
2014 Julia Gröger Comparison of the Pediatric Drug Legislation between US and EU Food and Drug Administration Safety and Innovation Act (Title V) versus EU Paediatric Regulation (EC) No 1901/2006 ***
2014 Katja Heiss EMA versus US-FDA regulatory requirements regarding bioequivalence of orally administered generics ***
2014 Dr. Florian Herb Impact of polymorphism of active pharmaceutical ingredients on the development of generic medicinal products ***
2014 Dr. Maria Iwe Commission Proposal for a Clinical Trials Regulation: implications for ethics committees
2014 Dr. Katja Jennißen Adaptive Licensing – A new approach in medicinal product authorisation ***
2014 Diana Jung Management of Worldwide Regional Regulatory CMC Requirements - An Approach by Creation of a CMC Database
2014 Dr. Johanna Kuhlmann-Gottke Regulatory requirements regardings cell-based medicinal products for human and veterinary use in Germany and Europe - a comparison ***
2014 Laura Liekmeier Best way to market for generics (DCP or CP) and the limitations due to a multi-brand marketing strategy
2014 Dr. Klaus Löchner Inclusion of the German purely national marketing authorisations in the scope of the Variations Regulation and use of the new Classification Guideline of 2013 in practice compared to the previous guideline and the former national German variation system ***
2014 Dr. Tina Lübbehüsen Real Time Release Testing - Challenges and Opportunities for the Pharmaceutical Industry
2014 Natalie Lubrich Einfluss von DRA auf das Tendergeschäft in Deutschland – Strategien eines mittelständischen Generikaunternehmens
2014 Dr. Sybille Meyer Animal Health market in the BRIC countries and comparison of its regulatory requirements for veterinary medicinal products with EU legislation ***
2014 Dr. Margarita Muiños Gimeno Regulatory Submission: from paper submissions to RPS ***
  • Total: 959