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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
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
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 ***
2007 Dr. Frank Jeblonski New developments in European registration procedures and requirements, in particular consideration of biological/biotechnological-derived medicinal products
2007 Dr. Anita Jörg Medicinal products during pregnancy and lactation – an issue of risk management ***
2007 Anja Karstens Differences between EU and US registration requirements for sterile human and veterinary products (quality part) for: a) First filing b) CMC changes
2007 Dr. Bianca Krafft Scientific Advice - Value Adding Strategies for Regulatory Agencies and Pharmaceutical Companies ***
2007 Michaela Krause ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System: vision, concept and their potential impact on industry and regulators – will they foster innovation? ***
2007 Ruth Lätzel Development of the ASEAN Pharmaceutical Harmonisation scheme - An Example of Regional Integration ***
2007 Kirsten Martin Readability User Testing of package leaflets: Regulatory requirements, methodologies and assessment ***
2007 Tünde Molnár Generics Medicines in the Centralised Procedure
2007 Dr. Katrin Neubert Development of a rationale for deriving acceptance criteria for the validation of analytical methods in the pharmaceutical quality control
2007 Angelika Ommeln Regulatory Data Analysis for the development of a database for country specific requirements ***
  • Total: 956