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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
2018 Elena Lang Eurasian medical device regulatory system - a new challenge or a new opportunity for European medical device manufacturers? ***
2018 Silvia Londero Brief analysis of the 'Guideline of manufacture of the finished dosage form' and its impact on the industry ***
2018 Dr. Sandra Mahr Replace, Reduce, Refine - Recent Developments in Alternative Testing Methods in Pharmaceutical Toxicology and their Regulatory Acceptability in the EU ***
2018 Dr. Larissa Maier International Regulatory Lifecycle Management of Gadolinum-based Contrast Agents ***
2018 Iulia Menzel Die Rechtsstellung des Informationsbeauftragten nach § 74a AMG ***
2018 Dr. Carola Michielse Guidelines and regulations on excipients in medicinal products: an overview of developments, implications and challenges for the future ***
2018 Dr. Markus Molitor The Relevance of the Label in the Context of the Early Benefit Assessment (EBA) of Medicinal Products: a Systematic Quantification of the Deviations of Marketing Authorization Labels Compared to the Underlying Pivotal Studies and the Consequences for the Extent of Added Benefit
2018 Aksana Müller Bioequivalence requirements in the Eurasian Economic Union, the European Union, the United States of America and the People’s Republic of China
2018 Dr. Natalia Osmanova Comparison of the regulation for Good Pharmacovigilance Practice in the European Union and in the Eurasian Economic Union ***
2018 Rosi Puniyani Introduction of the ICH Q12 (Draft) Guideline: An approach to a proactive evolution of a product- Chances, risks and practicability ***
2018 Dr. Lasse Reefschläger Analysis of the EMA relocation decision - regulatory reasoning and impact on regulatory functionality of the EMA
2018 Dr. Sam Ringle Regulatory Implications Using API Cocrystals for Generic Medicinal Products within the EU and US ***
2018 Andres Rodriguez Lüdke Assessment of Plants as Raw Materials / Resources for the Production of Medicinal Products in a Globalized Environment
2018 Dr. Helen Springer-Frauenhoff Life Cycle of CAR -T cell products: Legal framework and points to consider during the life of a CAR-T cell product
2018 Dr. Petra Starck-Lantová The role of animal studies in declining efficiency of pharmaceutical research and development from the regulatory perspective ***
2018 Theodor Tiko The regulatory landscape of human microbiome modulation using live microorganisms in the EU and US ***
2018 Theresa Vavvas Polycyclic aromatic hydrocarbons in (traditional) herbal medicinal products
2018 Sandra Wagner Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use authorized via the Centralized Procedure (2010 - 2017) ***
2018 Dr. Christopher Weber Regulatory environment for defined post-approval CMC Quality Control method changes of Biologics worldwide and implications for a suitable MAH change management
2018 Dr. Annika Wedeking US Regulation of Promotional Materials for Prescription Drugs: a Regulatory Perspective ***
  • Total: 720