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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
2005 Dr. Markus Hartmann Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology ***
2005 Dr. Marion Heinzkill Marketing Authorisation Procedures under the New Medicines Legislation – Impact on the Pharmaceutical Research Industry and Strategic Aspects ***
2005 Andrea Hörner Describe the CADREAC-procedure for a product which was authorized via mutual recognition procedure in the EU and ... ***
2005 Timea Janosi Parametric release of sterility of parenteral medicinal products
2005 Dr. Michael Klimars Global Requirements for Stability Testing - Are they Realistic for All Climatic Zones? –A Critical Evaluation ***
2005 Dr. Andrea Klüting The Effects of the 12th Amendment to the German Pharmaceuticals Act on Clinical Trials in Academic Institutions and the Pharmaceutical Industry ***
2005 Olena Krasichkova Design Qualification of a Small-Scale Freeze Dryer for Manufacturing of Ophthalmic Lyophilisate Carrier Systems
2005 Dr. Jutta Lange Tooth Bleaching Products - Medical Devices or Cosmetic Products? ***
2005 Stefanie Lemke Changes in the Field of Pharmacovigilance within the Scope of the 12th amendment and the drafted 14th amendment of the German Drug Law and the related EU legislation ***
2005 Dr. Daniela Lieder Evaluation and consideration of resistance data on the licensing process of antibiotics ***
2005 Anja Lindau HACCP-A description of the risk system and transference in the pharmaceutical industry
2005 Dr. Boris Mey Marketing authorisation of medicinal products used to prevent the toxicity of chemical, biological, radiological or nuclear substances (MA of Anti-CBRN Drugs) ***
2005 Dr. Wolfgang Meyer Preclinical and clinical development of anticancer drugs - regulatory peculiarities
2005 Dr. Eva-Maria Möllenhoff Requirements for active pharmaceutical ingredients in marketing authorization applications
2005 Katharina Neumann New Pharmaceutical Legislation (Review 2004) - The Impact on the Generic Industry
2005 Dr. Rainer Paffenholz Nonclinical assessment of immunotoxicity in the EU, United States, and Japan ***
2005 Dr. Karen Rosenkranz Regulatory strategies for life-cycle management of chemical defined cytostatic drugs with regard to the new pharmaceutical legislation ***
2005 Dr. Sabine Schiemann New aspects in comparability studies of biotechnological products subject to changes in the manufacturing process
2005 Ingrid Schulz Comparison of CMC requirements for Clinical Trials in the US and the European Union ***
2005 Dr. Daniel Schwarz Regulatory requirements in Europe for the development of active pharmaceutical ingredients derived from transgenic plants ***
  • Total: 969