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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 Dr. Elmar Wegener Real World Evidence - Impact on Regulatory Decision Making ***
2018 Dr. Stefan Werner Erörterung der Erstattungsfähigkeit von Flüssigbiopsie-Verfahren in Deutschland
2018 Patricia Westendorf How to update a CEP? An analysis of the regulatory activities in a middle-sized pharmaceutical company, taking account of the new Q&A of the EMA ***
2018 Angela Zambrano Global regulatory dynamics in response to the challenges of innovation in gene and cell therapy products: An overview
2017 Stefan Brunkhorst The Prescription Status and Its Implications for Pharmaceutical Companies ***
2017 Alice Burger Comparison of Pharmacovigilance in Germany and Japan ***
2017 Monica Cano History of attention deficit and hyperactivity disorder linked to Methylphenidate: A regulatory overview of the product lifecycle
2017 Dr. Thi Hong Nhung Do Options of innovative vaccine approval without human efficacy data ***
2017 Dr. Valeria Facchinetti Toward expanded patient access to gene and cell therapy products: a comparative study of the regulatory approaches in the European Union, the United States and Japan ***
2017 André Fischer The Swiss Überprüfungsverfahren – Similarities and differences to the EU Referral procedure ***
2017 Gabriele Gempel-Drey Medicinal products for geriatric patients in Germany - Current status of regulatory requirements and clinical reality ***
2017 Cordula Grandpierre-Verhees The challenge of filing a drug application for an NCE for human use for the US and EU in parallel - An overview of the potential differences between the US and EU CTD dossiers and essential pre-application activities
2017 Dr. Rita Grimm Use of Extrapolation, Modelling & Simulation Studies in Paediatric Investigation Plans – an analysis of PIP opinions from 2007 – 2016 ***
2017 Dr. Ulrich Heiser Evaluation of Recent Scientific and Regulatory Developments in Alzheimer's Disease and Their Impact on the Clinical Development of a Disease-Modifying Therapy ***
2017 Dr. Sandra Hennig Companion Diagnostics for Personalised Medicines – the Regulatory Framework for their (co-) Registration in the EU and the USA ***
2017 Dr. Gunther Kauselmann Precision Medicine and the N-of-1 Clinical Trial Concept ***
2017 Diane Kleinjohann Regulatory aspects concerning extracts from cannabis with low Δ9-tetrahydrocannabinol content
2017 Dr. Jenny Lauterbach Beauflagte Schulungsmaterialen als zusätzliche Risikominimierungsmaßnahme in Deutschland. Eine kritische Analyse aus Sicht der Industrie, der Ärzte und Behörden ***
2017 Dr. Andreas Lippert Quo vadis phase I trials in the EU?
2017 Dr. Helen Meyer-Martin The increasing burden of Allergic Asthma – Regulatory framework of common treatment strategies and innovative therapies
  • Total: 720