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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
2020 Lian Gelis Software and Wearables as Medical Devices - Regulatory Considerations for Application in Clinical Trials ***
2020 Meike Herrmann Assessment of European Union referral procedures (human, post-authorisation) triggering the implementation of risk minimisation measures as outcome after European Commission decision
2020 Nicole Heumesser Proposal for a Harmonised Structure of Technical Documentation and basic Functionalities of a Submission Software Tool under EU-MDR ***
2020 Dr. Esther Hindricks Assessment of nitrate, nitrite and nitrosamine exposure resulting from food, medicine intake, chemical and environmental contamination
2020 Dr. Stefanie Hirsch Vergleich der deutschen und Schweizer Vorgaben zur Erstellung der Fachinformation für Humanarzneimittel mit Fokus auf chemisch-synthetische Wirkstoffe ***
2020 Dr. Jonas Kosten Comparative evaluation of AAV gene therapy, antisense therapy and small molecules therapy for treatment of SMA for efficacy and safety ***
2020 Anja Krug (geb. Mändl) Accelerating Access to Medicines in Developing Countries - an Evaluation of EU-Medicines4all (formerly Article 58 procedure) ***
2020 Christof Kugler Developmental and Regulatory Challenges Regarding AAV-Based Gene Therapy for CNS Disorders ***
2020 Elisabeth Kuhn Changing landscape in clinical drug development - New regulatory challenges in clinical trial designs
2020 Dr. Anja Limberg Comparison of vigilance legislation – Procedures for medical devices and medicinal products ***
2020 Marleen Lipinski Incorporating Patient Perspective into Benefit-Risk Assessments of a Medicinal Product - An Inventory of the Regulatory Approaches established in the European Union and the United States ***
2020 Mohamed Akram Maaouia The Maghrebian Region – current situation and regulatory framework concerning marketing authorization process in comparison with Europe - Could a centralized System for the Maghreb be built?
2020 Anna Magg Does the SSCP bring the desired transparency for the European patients and the general public - Critical Assessment from an industry perspective
2020 Dr. Sonja Matt Regulatory considerations for the development of next generation antibody-based therapeutics: Historical overview and quality requirements in the EU ***
2020 Dr. Daniela Matthey-Inführ The new guideline ICH Q12 and its application to the production transfer of European approved and approvable medicinal products to a new manufacturing site - Does it provide any new benefits for the regulatory strategy? ***
2020 Monique Mendel-Ott The impact of changing legislation on the development, marketing authorisation and commercialization of medicinal products ***
2020 Mariam Motamen Simplification Instead of Complication: A Critical Assessment of Pharmacovigilance Legislation from an Industry Perspective ***
2020 Dr. Christina Nöcker Implementation of TPO IV in Switzerland - implications for regulatory strategies and comparison with the European legislation ***
2020 Kateryna Popova Normative Documentation in CIS region. Challenges for an EU Marketing Authorization Holder ***
2020 Dr. Claudia Isabel Reichmann Diskussion über die Neuauflage der Richtlinien für die Herstellung von Plasma für besondere Zwecke (Hyperimmunplasma): Ein regulatorischer Prozess
  • Total: 967