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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
2014 Kolmal Musa Regulatory Intelligence in the Development of OTC Products ***
2014 Sandra Rauch Impact analysis respective the switch from NtA or CTD submissions (paper or NeeS) to eCTD submissions for medicinal products for human use in the EU being newly applied or already authorized– exemplified for Germany (BfArM) ***
2014 Melanie Rosslan Regulatory Strategy for an efficient launch of medical devices - a distinct focus on BRICS and MIST countries ***
2014 Nahid Roushanaei The New Regulation 536/2014 on Clinical Trials on Medicinal Products for Human Use – Opportunities and Challenges for European Clinical Research ***
2014 Dr. Anna Schnitger The Hospital Exemption, a regulatory option for unauthorised advanced therapy medical products ***
2014 Dr. Alexandra Schubert The Regulatory Environment in Nanomedicine: A Comparison between US, EU, Canada and Australia in Assessment of Anticancer-Therapies ***
2014 Dr. Melanie Schüppel Educational material as important risk minimisation measure and procedure of agreement with the competent authority ***
2014 Lennart Seidler ICH Q3D and related impurities in antibiotics – new requirements for Active Substances in Europe ***
2014 Dr. Awinder Sohal Kauselmann Comparison of the labelling processes of human and veterinary medicinal products with an emphasis on the development and post-marketing maintenance activities of labelling
2014 Dr. Stephanie Sommer Regulatory acceptability of clinical surrogate endpoints for accelerated (US) or conditional (EU) approval of haematological anti-cancer drugs in the light of the new CHMP anti-cancer guideline (CHMP/205/95 Rev. 4 and appendices) and the new FDA draft guidance on expedited programs for serious conditions ***
2014 Dr. Silvia Specker Global Regulatory Registration Plan for a Fixed-dose Combination in the Indication of Hypertension in the European Union, the Unite States of America and selected Emerging Markets ***
2014 Dr. Georg Tschank The Impact of the EMA-EUnetHTA Collaboration on Drug Development ***
2014 Dr. Anke Webler-Messenger The Company Core Data Sheet: From CIOMS to the implications of the new Pharmacovigilance Legislation ***
2014 Britta Weingarten Current drug safety measures for thalidomide and their national implementation in Germany and the UK ***
2014 Frauke Wellhausen Challenges in the regulatory requirements for homeopathic medicinal products in Canada and the European Union with Germany and Belgium as examples under special consideration of recent developments ***
2014 Dr. Susanne Weyel-Schnurrer Comparative Presentation of the Procedure of Active Substance Master File & Certificate of Suitability and the Implication on the Marketing Authorisation Dossier ***
2014 Dr. Uta Wrackmeyer The process of implementing Directive 2010/63/EU into German law
2014 Jing Yuan Comparison of Medical Devices Regulations in the EU and the People's Republic of China-Current situation and possible implications of the new Chinese Medical Device Guideline (2014)
2014 Dr. Yuan Zhao The regulatory process of electronic submission and its optimization
2013 Dr. Heidrun Albrecht Experiences with PIPs and their required revisions on the critical path of the development of medicines in indications for adult patients ***
  • Total: 959