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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
2010 Viktoria Behse Current experience with PIP approvals ***
2010 Dr. Anne Benzinger Regulatory requirements for preclinical development of bispecific antibodies ***
2010 Hanna Bölke Harmonisation of Product Information Texts of Generic Medicinal Products in EU – And its Impact on the Necessity of User Testing and Bridging
2010 Dr. Jasmin Fahnenstich Prescription of Cannabis - Regulatory environment and current situation in Germany in comparison with the Netherlands and the USA ***
2010 Dr. Sabine Frenzen Regulatory Requirements for Biocidal Products in Comparison to Medicinal Products within the EU ***
2010 Dr. Anita Friedrich Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use Authorised via the Centralised Procedure (1995 –- 2009) ***
2010 Anna Geist Special consideration of OTC switches with respect to application and national implementation from the generic perspective ***
2010 Dr. Uwe Goßlar What are the prospects for a global "biosimilar"development? Comparison of the regulatory requirements for the marketing authorisation of biosimilar products using the example of implemented or proposed legislation in the EU, Canada, Japan and the proposed WHO guidance ***
2010 Minna Haapalahti Overview of Pathogen Inactivation of Blood Components versus Emerging Pathogens – Measures and Implementation Status ***
2010 Anne-Kathrin Heese Submission of variations to implement changes in the product information texts following European Paediatric Work Sharing Procedures according to Article 45/46 of Regulation (EC) No 1901/2006 - from the point of view of a generic company ***
2010 Thomas Hengelage News in nonclinical evaluation of anticancer pharmaceuticals: ICH Guideline S9 and beyond ***
2010 Dagmar Hintz System regulating Medical Devices for Use in Animals
2010 Santy Kerb Application of Company Core Data Sheet (CCDS) in globally established medicinal products to ensure the accuracy of product information across international markets
2010 Annette Kiesewetter The Declaration of Helsinki and its Revisions – A Mirror of the History of Ethical and Social Debates in Clinical Research
2010 Dr. Claudia Matthies Regulatory Requirements for Medical Devices in Southeast Asia and China ***
2010 Gudrun Pfeffer Biologics in Emerging Markets - Regulatory Strategy and Requirements
2010 Frank Pietsch Clinical Trials with Pharmaceuticals for Human Use - Ethical and Regulatory Aspects, Future Challenges
2010 Dr. Johanna Roggemann An overview on the requirements for the acceptability of invented names for human medicinal products in the Centralised Procedure ***
2010 Dr. Christiane Rothkegel Impact of Clinical Trial Registration on the Future of Drug Research ***
2010 Ridwan Sarwin Assessment of the new EU variation regulation No 1234/2008/EC on the practicality aspects for post-approval changes of human medicinal products
  • Total: 720