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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. 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 Sandra Schneidereit, (geb. Nehlsen) The Escitalopram Case: A Comprehensive Strategy Allowing for Early Market Access of a Generic Drug
2008 Carola Seidel Das IQWiG als neuer Eckpfeiler bei der Entscheidungsfindung des Portfolios der Generikaunternehmen
2008 Dr. Patricia Stöhr The Regulatory Environment for Vaccine Development - a Challenge for Industry
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 Dr. Benita von Glahn Post marketing Activities in Japan compared to EU and USA
2008 Dr. Martin Wendland Regulatory guidance on comparability studies for biological products following changes to the manufacturing process and analytical procedures
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. Ludger Benning Electronic Submission and the MRP/DCP: How to Compile a Dossier That Will be Accepted at the European Agencies ***
2007 Dr. Michael Bernhard Quality attributes of biopharmaceuticals: The impact of glycosylation ***
2007 Dr. Georg Brauers Regulatory Aspects of Pharmacogenomics in Clinical Drug Development ***
2007 Jörg Cselovszky The New Regulatory Framework for Health Claims in the Eurpean Union – Impact on the Demarcation of Food to Medicinal Products? ***
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 Ellen Frey-Stanislawski Revision of the Variation Regulations Commission Regulation (EC) No. 1084/2003 and No. 1085/2003 - Industry-Proposals and Consultation Paper from the European Commission, Impact on Industry and Health Authorities ***
2007 Dr. Ulrich Fritsche An Overview of the Regulatory Framework of Fixed Dose Combination Medicinal Products (FDC)
2007 Lena Gebert Impfstoffe für den Menschen - Ein Leitfaden über die besonderen arzneimittelrechtlichen Regelungen aus dem Arzneimittelgesetz ***
2007 Anneke Hackling Clinical Trials in China
  • Total: 969