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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. 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 Dr. Katrin Neubert Development of a rationale for deriving acceptance criteria for the validation of analytical methods in the pharmaceutical quality control
2007 Michaela Oppold The opportunities of the new Regulation on medicinal products for paediatric use for existing marketing authorisations – on the example of an off-patent drug substance
2007 Ariane Prochaska Assignment of GMP data - within application dossiers and during external inspections
2007 Dr. Ursula Protin First experiences with Conditional Marketing Authorisations in the EU: requirements, obligations, initial experiences and perspectives ***
2007 Susanne Rathmann Site Master File, a competent regulatory document ***
2007 Dr. Herta Reile Implications of the new CHMP Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products Summary ***
2007 Dr. Tatjana Reinholz Life cycle management of a marketed medicinal product in view of GMP and regulatory requirements and impact of Product Quality Reviews ***
2007 Dr. Silvia Sanner Registration Procedures in South Africa
2007 Dr. Dirk Schmidt Impact and Consequences of the PAT Initiatives by FDA and EMEA on New Chemical Entity Synthesis ***
2007 Karin Schöpf Global Pharmaceutical Markets and the Influence of the International Organizations WHO and ICH ***
2007 Dr. Susanne Sommer Package Leaflets: Testing and harmonisation in relation to the overall business process in regulatory procedures - An example of the impact of changing regulatory requirements ***
2007 Dr. Dagmar Theis Legal Framework for Compassionate Use in the European Union - Comparison of the Implementation of Compassionate Use Programmes by Means of Selected European Member States
2007 Sabine Wägele The Global Marketing Authorisation according to Article 6 of Directive 2001/83/EC, as amended ***
2007 Dr. Nicole Wagner International Nonproprietary Names (INNs) - A Critical Issue For Biological Medicinal Products ***
2007 Dr. Michael Walser Analytical Method Validation: Compilation of Relevant Legislation, Guidelines, and Literature
  • Total: 720