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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 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 Dr. Zoran Pavlovski Essential regulatory requirements in the United States related to medical devices intended for human use
2007 Wieland Peschel The regulatory challenge to improve the safety of Traditional Herbal Medicinal Products in Europe ***
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. Peter Satter Assessment of potential similarity between orphan drugs
2007 Dr. Katja Schepper Clinical requirements for the development of biosimilar products ***
2007 Dr. Ursula Schickel The impact of the revised EU-legislation concerning particular needs of blind and partially-sighted patients and user testing – a challenge for pharmaceutical companies with focus on Germany ***
2007 Dr. Dirk Schmidt Impact and Consequences of the PAT Initiatives by FDA and EMEA on New Chemical Entity Synthesis ***
2007 Dr. Sabine Schmitz Pharmaceutical Excipients – Regulatory and GMP Requirements ***
2007 Karin Schöpf Global Pharmaceutical Markets and the Influence of the International Organizations WHO and ICH ***
2007 Dr. Desi W. Soegiarto Changes of Pharmacovigilance Requirements within the Scope of Volume 9A and Related EU Guidelines
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 Seval Tangut New Regulatory Environment in Turkey
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 ***
  • Total: 956