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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?
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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
2008 Petra Kist Pharma-Mittelstand - Drug Regulatory Affairs Portfoliostrategie ***
2008 Dr. Uta Klöcker Marketing authorization of placebos –legal requirements and requirements to the dossier in accordance to the German drug law
2008 Dr. Michael Lammers Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products ***
2008 Dr. Karin Markgraf Biosimilars in the EU and in the US
2008 Dr. Beatrix Metzner Comparison of marketing authorization procedures for biotechnological products in the European Union (centralized procedure) and in Japan (J-NDA) ***
2008 Britta Neubauer CMC Documentation Contemplation on regulatory requirements in relation to the maintenance of drug products concerning life cycle and change management
2008 Stephanie Pick Die Packungsbeilage als Instrument der Verbraucherinformation im Wandel der Zeit ***
2008 Dr. Tatiana Reimer Impact of scientific advice on the outcome of marketing authorisation applications submitted to the CHMP between 2004 and 2007 ***
2008 Dr. Barbara Römer 2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe ***
2008 Jörg Schneidereit An Approach to Abbreviated New Drug Applications (ANDA) and Question based Review (QbR) ***
2008 Florian Strohmaier Evaluation of the legal basis of biological and biotechnological product applications in Europe and US and discussion of consequences for similar biological medicinal product applications
2008 Dr. Sanjiv Verma The Regulatory Framework concerning the Import of Medicinal Products in India and in the European Union (e.g. Germany)
2008 Frank Zimmermann The Centralised Procedure from the Micro, Small and Medium-sized Enterprise's Perspective and Specific Obstacles of SMEs ***
2007 Dr. Joachim Ahlert ICH Q8: Pharmaceutical Development. Regulatory Requirements Directed by the New Note for Guidance (EMEA/CHMP/167068/2004) in Comparison to the Previous Guideline (CPMP/QWP/155/96). A Critical View from the Generic Pharmaceutical Industry. ***
2007 Dr. Georg Brauers Regulatory Aspects of Pharmacogenomics in Clinical Drug Development ***
2007 Claudia Fischer Investigational Medicinal Product Dossier (IMPD): CHMP/QWP/185401/2004-Guideline (Note for Guidance on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical trials): Comparison of requirements described in this guideline and in additional national guidance documents from exemplary EU countries and the emerging country India. Discussion of the impact on the compilation of a global IMPD for a multi-centre study
2007 Dr. Ulrich Fritsche An Overview of the Regulatory Framework of Fixed Dose Combination Medicinal Products (FDC)
2007 Yuwei Heinzel Regulatory Impact of the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) on the Pharmaceutical Development
2007 Elvira Holder Comparison of the requirements for simplified registration and marketing authorization procedure of homeopathic products with Austria, France, Germany, Italy and Switzerland
2007 Wiebke Hoppensack Triggers for Regulatory Changes – Implication of the TGN1412 incident on regulatory requirements for first-in-man trials ***
  • Total: 720