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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
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
2012 Dr. Holger Berk The legislative framework for veterinary medicinal products in Europe under revision - A review on primary objectives, key issues, policy options and their impact assessment
2012 Prof. Dr. Dr. Thomas Bieber Stratified medicine: A new challenge for the academia, industry, regulators and patients ***
2012 Christian Biegel EudraVigilance Medicinal Product Dictionary - a challenge for authorities and marketing authorisation holders
2012 Jürgen Blömer User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe
2012 Nicole Dévaud Veterinary medicinal products authorised for rabbits in the European Union - Causes for insufficient availability and consequences on human and animal health ***
2012 Dr. Axel Dienemann Pharmaceutical development of medicines for paediatric use - requirements, challenges and implications
2012 Dr. Sven Enders Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts
2012 Stephanie Gelsen Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline
2012 Dr. Astrid Gerhardt Exceptional Japan filing of a biologic mature product
2012 Christian Hanke Project-, Drug-, and Business Development in a Biotech SME ***
  • Total: 969