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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
2019 Dr. Melanie Mühlfelder Real-life experiences with approval of pediatric clinical trials in Germany
2019 Dr. Olga Nilmayer Regulatory requirements concerning the manufacture and clinical use of human cornea in Germany ***
2019 Stefanie Rodler Elemental Impurities in Drug Products: Challenges for the pharmaceutical industry in establishing limits based on ICH Q3D for alternative routes of administration ***
2019 Dr. Mareike Schnaars Regulatory Challenges and Strategies for Allergen Products in the European Union and Canada ***
2019 Caroline Schommer MDR's Article 117: Regulatory Strategy to Comply With the General Safety and Performance Requirements Set Out in Annex I in the Light of a Single Integral Drug Device Combination ***
2019 Carina Schunk Regulatory requirements related to the registration of generic orally inhaled drug products in the EU and US - A comparison of the European "stepwise approach" and US "weight of evidence approach" ***
2019 Dr. Karim Sempf The Valsartan Case and its Consequences for the Global Supply of Pharmaceutical Active Ingredients
2019 Theresa Sorgenfrei Readability and comprehensibility of package leaflets - recent efforts for improvement within the EU and a historical review ***
2019 Dr. Ansgar Stüken The New ICH Guideline ICH S5(R3) on Reproductive Toxicology on Medicinal Products for Human Use - Opportunities and Challenges for European Non-Clinical Drug Development ***
2019 Dr. Alexandra Thornagel Implikationen von Artikel 31-EU-Referrals in Deutschland am Beispiel von Metformin (EMEA/H/A-31/1432) und Valproat (EMEA/H/A-31/1454) ***
2019 Heike Trautmann Regulation (EU) 2015/2283 on novel foods - Analysis of the amendments and their impact on regulatory work ***
2019 Dr. Anja von Au Medical device safety reporting in clinical investigations and PMCF studies under the new MDR - A comparison to the current German legislation
2019 Dr. Oliver Walisko Potency Assignment of Factor IX Medicinal Products for the Treatment of Hemophilia B: Regulatory meets Practice ***
2019 Susanne Werk The European MDR and its potential impact on the existing German legislation on medical devices and the status of the discussion on the interpretation of several requirements of the MDR
2019 Fabian Witzel Standardization as Key for Global Digital Health Regulatory Affairs Improvement ***
2019 Dr. Nicole Woik Comparative analysis of the strategies for implementation of the Clinical Trials Regulation (EU) No 536/2014 in Europe ***
2019 Dr. Daniel Zucker Implementation of Regulatory Requirements for Lipid based Excipients - Claims and Reality
2018 Carlos Canete Bacteriophage therapy: an analysis of the European regulatory framework and its proposals for amendment ***
2018 Lais da Silva Critical Assessment - Implementation of ICH Guidelines in Brazil ***
2018 Sofia Dust Impact of China's regulatory reforms on business operations in Chinese pharmaceutical market: Perspectives and Challenges for multinational pharmaceutical companies ***
  • Total: 969