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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 Zohaira El Malahi Maintenance of Marketing Authorizations of Medicinal Products in the MENA Region – Differences and Similarities to European Procedures ***
2018 Sebastian Fischer The 2017 EC Report on the Paediatric Regulation - A critical analysis of stakeholder positions ***
2018 Dr. Maxim Frizler GVP module V revision 2 a review of recommendations and main changes
2018 Dr. Karin Geßele Regulatory Framework and Challenges for Approval of "Generic" Non-biological Complex Drugs (NBCDs) ***
2018 Mareike Gleissner New Legal Framework for Food for Special Medical Purposes - Implications on Demarcation and Regulatory Requirements at European Level and in Germany ***
2018 Dr. Florian Haberl IDMP - a business driver for implementation of a company wide master data management system in pharmaceutical companies
2018 Hannah Hähl Adaptive Pathways - Challenges of a global development program for early patient access in the context of the current Health Care System and Health Technology Assessment Landscape in Europe, USA and Japan
2018 Dr. Susan Heller Harmonisation of quality dossier following Union Referral - Challenges and points to consider with focus on sterile finished products ***
2018 Dr. Claudia Heß Expectations of eCTD 4.0 - also a step forward for small and medium sized enterprises? ***
2018 Sylvia Hinderfeld Labelling Requirements for Clinical Trials in the EU - Overview of current and future requirements when Regulation (EU) 536/2014 applies ***
2018 Christoph Hoerth Change of a starting material supplier Comparison of the global post authorization change requirements with focus on the API class of synthetic peptides
2018 Dr. Jutta Keil The representation of transdermal systems in the leading pharmacopoeias within the ICH-area and the elaboration of transdermal finished product Monographs ***
2018 Maria Keyser Avoiding of falsified medicines: An overview of the legal situation and the impact on the pharmaceutical industry - with a focus on regulatory implementation
2018 Rosanne Kirchberg Cannabis in Switzerland: Considering Historic, Legal and Regulatory Aspects With Focus on Medicinal Use
2018 Elizabeth Klemm Clinical trials in Central America: an analysis of the low MRCT allocation to this region by comparing the regulatory requirements in Cuba, Dominican Republic and Puerto Rico with EU standards
2018 Ralf Klünder Besonderheiten der Arzneimittelzulassung in der Katastrophenpharmazie unter Mitbetrachtung des Geschäftsbereichs BMVg - eine Einschätzung
2018 Michael Kravzow Regulatory considerations, opportunities and challenges for pharmaceutical companies in developing a multi-vitamin/mineral product ***
2018 Sarah Kruck EU Herbal Monographs - chances and limitations in Regulatory Affairs
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 ***
  • Total: 969