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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?
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Dr. Jasmin Fahnenstich

Dr. Jasmin Fahnenstich

Study programme manager

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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
2013 Dr. Marion Petra Schergaut Human Generic Drug Requirements in the APAC Region: Distinctions and Similarities Influencing the Development Strategy
2013 Dr. Karin Schleisiek The new role of excipients: Developments in the framework of GMP and the impact for the pharmaceutical industry
2013 Simon Schmidmeier Two years AMNOG and early benefit assessment pursuant to § 35a SGB V - a critical review from the manufacturer´s point of view
2013 Marlene Schulzensohn How to place human medical devices on the market? An overview and critical examination of the regulatory requirements in Germany versus those in the United States ***
2013 Dr. Verena Schummer Developments in anticancer immunotherapies for use in combination ***
2013 Dr. Christin Selent-Stier Development of an adequate strategy for a global change in the primary container closure system of a parenteral herbal drug ***
2013 Svenja Seyler-Junker Evaluation of design and layout of folding boxes of centrally approved medicinal products using a decision matrix developed from legal requirements and available guidance documents ***
2013 Dr. Amir Saeed Sheikholeslam Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System ***
2013 Dr. Sebastian Specht ICH - Strengths, Weaknesses and Future Tasks
2013 Beate Stadler Pharmacovigilance Referrals - Changes in line with the new Pharmacovigilance Legislation 2010 / 2012 ***
2013 Dr. Silke Stender Regulatory requirements for products used for In-vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) according to MEDDEV 2.2/4 ***
2013 Dr. Max Storf The impact of FDA and EMA guidances regarding Patient Reported Outcomes (PRO) on the drug development and approval process ***
2013 Dr. Marion Tegeler Regulatory Requirements & Cultural Challenges for Registration of Generic, Human, Oral Medicinal Products in Southeast-Asia: A Comparison of Regulatory Efforts Exerting to the Registration Process in Malaysia, Thailand and Vietnam ***
2013 Imke Teuffel von Birkensee A Regulatory View on Application Devices ***
2013 Andreas Vogt The planned transformation of Directive 98/79/EC on in vitro diagnostic medical devices into a Regulation. Possible regulatory consequences for the development and release of in vitro diagnostics ***
2013 Ariane Wölfer Regulatory requirements for clinical trials in Singapore, Hong Kong, Taiwan and South Korea -hurdles and opportunities, and development strategies
2013 Alexandra Zoller Implementation of a global regulatory change control process – challenge and chance for a generic pharmaceutical company "Definition of a regulatory change control process taking different regulatory requirements regarding change control of different countries (e.g. differences within EU vs. US) into account to ensure a constant supply chain" ***
2013 Florentina Zymberi Regulatory electronic Document Management System (eDMS) in the pharmaceutical industry
2012 Elwira Baldyga Biosimilars in the EU and the USA: Impact of regulations on the development, registration and marketing process and consequences from the reimbursement system in Germany
2012 Marcus Baur Choice of study location for a First-in-Human study with a biological product - a critical decision for a biotech company
  • Total: 959