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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
2004 Britta Ginnow Impact of the new Variation Regulations 1084/2003 and 1085/2003 on the industrial practice of a multinationally operating pharmaceutical company with regard to the EU enlargement and the multinational procedure in performing variations ***
2004 Dr. Daniel Gommel Developments in Regulatory Pharmaceutical Toxicology:
2004 Dr. Gisela Greger Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products ***
2004 Dr. Ulrike Greger Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland ***
2004 Dr. Heribert Halex Regulatory Aspects of Stability Testing of vaccines representative of Biological Medicinal Products
2004 Dr. Petra Heyen Regulatory Intelligence as the basis for Regulatory Strategy and Global Drug Development ***
2004 Anja Hilse Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing for blister packs
2004 Dr. Thomas Lauterbach Characterization of Impurities during Development of Chemically Synthesized Compounds Regulatory Requirements ***
2004 Jiqing Madeleine-Wang A Comparison of Generic Submission in Europe and in Asian Countries
2004 Viraj Mehta Trade Related Aspects of Intellectual Property Rights and Pharmaceuticals: The Impact of Extended Protection on India ***
2004 Dr. Ursula Moosbauer The Impact of Stereoisomerism on the Regulation Procedure on the Example of Antibiotics ***
2004 Barbara Ost Accreditation of a control laboratory for testing of medicinal products
2004 Dr. Beate Preuss Quality related changes during the life-cycle of a medicinal product marketed in the EU and their impact on the pharmaceutical documentation (CTD module 3)
2004 Dr. Jan Richter Scientific and regulatory concepts for the development of molecular targeted anti-cancer drugs ***
2003 Dr. Robert Alz Antimicrobial Drug Resistance - Impact on the Pre- and Postlicensing Process of Veterinary Medicinal Products in the European Community
2003 Dr. Christine Bautz The legal status of medicinal products: Potential problems arising in case of a compulsory harmonisation as discussed in the current revision of the EU legislation ***
2003 Dr. Michael Berntgen Exploring Paediatric Indications for Off-patent Drug Substances - Strategic Input of Regulatory Affairs ***
2003 Loneliese Canali The different regulatory requirements for conducting clinical trials in the EU and the consequences for multinational studies. How will these procedures be changed by implementation of the Clinical Trial Directive 2001/20/EC? ***
2003 Veronika Etges CMC - Variation in a Globally Operating Pharmaceutical Company ***
2003 Dr. Roland Kröger Pharmacovigilance Critical Assessment of Current Regulatory Issues with Special Regard to Urgent Safety Restrictions ***
  • Total: 720