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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
2008 Dr. Derk Eldert Görich One Step beyond the eCTD: Update of the Dossier by electronic Variations In Europe and Germany
2008 Dr. Andreas Grummann Strengthening and Rationalising the European Pharmacovigilance System ***
2008 Nadine Herzog Optimisation of Master File Procedures for Biologics: Comparison of Master File Procedures - EU and USA ***
2008 Dr. Monika Hitzl Global regulatory requirements and how to reflect them in the process control system of pharmaceutical industry - Implementation of Process Analytical Technology
2008 Heli Hulkkonen Generic Medicinal Products – A Comparison of Regulatory Framework between Germany and Finland ***
2008 Susanne Igl Quality of Medical Devices Incorporating a Medicinal Substance Having Ancillary Action in the EU – Requirements According to Medical Device Regulations and According to Medicinal Products Regulations
2008 Rita Jochum Necessity of consultation procedures on medical devices incorporating a medicinal substance ***
2008 Dr. Astrid Kaufmann Is ‘Readability Testing’ an adequate procedure to improve the legibility of package leaflets? A European comparison including German and British liability aspects
2008 Saskia Kissel Gibt es eine Zukunft für die Standardzulassung in Deutschland?
2008 Petra Kist Pharma-Mittelstand - Drug Regulatory Affairs Portfoliostrategie ***
2008 Oliver Klaas Process validation of a medicinal product: Compilation of relevant legislative, guidelines and literature
2008 Dr. Uta Klöcker Marketing authorization of placebos –legal requirements and requirements to the dossier in accordance to the German drug law
2008 Dr. Christian Kutzleb Comparison of the Regulatory Environment to Authorise so-called Combination Products Consisting of a Drug and a Medical Device in the US and the EU ***
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 Beate Menkel License Application in India with Special Regard to Vaccines
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 ***
  • Total: 969