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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

Downloads from A-Z

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
2023 Dr. Irina Anusca Clinical Evaluation of light-cure resin modified Dental Composite according to MDR 745/2017
2023 Deanna Yuching Balakhonova An Overview of Current Regulatory Environment Regarding Artificial Intelligent (AI)-Based Medical Device Software (MDSW) in EU
2023 Justin-Christopher Bell Regulatory Informatics and Labelling Management Systems - Recent Developments and Description of a State-of-the-Art Labelling Management Software in the Pharmaceutical Industry ***
2023 Katharina Böhm Clinical Trials Regulations (CTR) – An analysis of the first clinical trial applications in the public portal of the Clinical Trials Information System (CTIS) ***
2023 Marianna Costa The regulatory challenge of determining acceptable intakes for nitrosamine drug substance-related impurities while ensuring medicinal product supply ***
2023 Dr. Harald G. Engemann A comparison of the regulatory requirements for the conduct of clinical trials respectively performance studies for medicinal products, medical devices and in-vitro diagnostic medical devices according to the European regulations (EU) 536/2014, (EU) 2017/745 and (EU) 2017/746
2023 Dr. Denise Nadine Fabian Labeling of Drug-Device Combination (DDC) Products in Europe under the new Medical Device Regulation (EU) 2017/745 ***
2023 Dr. Naséra Hammouti Worldwide Good Distribution Practice (GDP) guideline: a regulatory need and challenge
2023 Dr. Martina Hänsel Das Gender Health Gap in der Arzneimittelforschung und bei der Arzneimittelzulassung innerhalb der Europäischen Union – Spiegelt sich eine Berücksichtigung von geschlechtsspezifischen Unterschieden in den regulatorischen Rahmenbedingungen und in den Produktinformationen wider? Eine Betrachtung anhand der Beispiel-Indikationen Rheumatoide Arthritis (RA) (2017 - 2024) und COVID-19 (2020 - 2024) ***
2023 Yvonne Hinterstocker Comparison of the regulatory requirements for the proof of comparability of generic locally applied locally acting products with their originator product in the EU and USA - an overview on the current status and the latest trends
2023 Nicola Leven Preparation of a specification and description of the process validation on the manufacturing process of biological active substance streptokinase as part of the drug master file for the EU ***
2023 Daniela Maier Sind die neuen regulatorischen Bedingungen für minimalinterventionelle klinische Prüfungen praxisrelevant für klinische Prüfungen nach der Marktzulassung?
2023 Syed Saadi Manzoor The placing on the market of in vitro diagnostic medical devices under the old and new legal situation with special consideration of the possibility of a special authorization - Legal basis and Regulatory Aspects -
2023 Dr. Olga Petina Comparative analysis of the EU regulatory requirements for essential oils as ingredients for the pharmaceutical, cosmetic products and feed additives ***
2023 Kay Pötzsch "The Fair Minimum": Wie deutsche Arzneimittelproduktinformation geschlechtsneutral werden kann ***
2023 Ketki Revashankar Purohit A retrospective landscape assessment of the use of real-world data in the FDAs recent (Jan 2019-Jun 2022) regulatory decision making for the pharmaceutical products ***
2023 Dr. Bernhard Richard Assuring data integrity for CMC regulatory submissions using custom digital tools ***
2023 Annette Rogge-Toehgiono Use of digital technologies in healthcare: approvals in the borderline area between medical device and medical aid – investigation and evaluation of regulatory chances and challenges - medical software applications ***
2023 Dr. Verena Schipper Real-world evidence in the German HTA process – acceptance by G-BA in the European regulatory and HTA context ***
2023 Norbert Schmid-Eickhoff Compassionate Use in Deutschland - eine Übersicht der regulatorischen Rahmenbedingungen und Analyse der durchgeführten Verfahren seit Inkrafttreten der Verordnung über das Inverkehrbringen von Arzneimitteln ohne Genehmigung oder ohne Zulassung in Härtefällen (AMHV), 2010 ***
  • Total: 950