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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
2011 Elke Gurschke Best Practice Guide for Regulatory Affairs in a German CRO - From Application to Clinical Trial Report: Implications of Well-Structured Completion of Relevant Steps ***
2011 Christian Heringer Regulatory requirements for the sterilization of medical devices
2011 Dr. Kirsten Jacobs Regulatory Requirements for medical devices in major countries of Latin America
2011 Susanne Junker, geb. Weber Preparation of a meaningful and appropriate risk management plan a multifunctional task ***
2011 Kristiane Kempny Approval of a biological medicinal product within the Mutual Recognition Procedure (RMS: Germany) - regulatory strategies and potential challenges from a consulting company's point of view with regard to current pharmaceutical legislation ***
2011 Silke Dorothea Kilzer Development of the Counterfeit Directive - More confidence in the legal supply chain? (Focussed on "Basic Requirements for Active Substances used as Starting Materials": ICH Q7, GMP) ***
2011 Dr. Dorothee Klinkowski Implications of the German Regulation on Therapy Allergens ("Therapieallergene-Verordnung") on the allergen manufacturing industry
2011 Christophe Klumb Making cellular therapies available to patients - Possible regulatory pathways in Europe and Germany ***
2011 Stefanie Lauhoff Die Überarbeitung der Packungsgrößenverordnung im Rahmen des AMNOG und deren praktische Auswirkungen ***
2011 Dr. René Leubert The Design Flexibility in Monographs for Excipients
2011 Dr. Stefan Leyers 'Chemo-similars', a new challenge for regulatory affairs?!
2011 Dr. Qiaoqian Luethi-Peng Comparative review of prescription drug labeling requirements across various regions and considerations for managing Company Core Data Sheet
2011 Daniela Meinl DCP Slot Allocation within European Health Authorities and its impact on Development and Regulatory Strategies of Generic Companies Summary
2011 Natascha Nickelt Regulatory Assessment of Nanotechnology in Different Areas of Application -an Example of Regulating Emerging Sciences ***
2011 Dr. Gabriele Noffz Novel biomedical products: Conventional biologicals or ATMPs ***
2011 Dr. Janni Papakrivos Regulatory Strategy for the Development of Known Drugs in New Therapeutic Areas ***
2011 Christina Pfaffendorf Development of Generic Oral Human Medicinal Products Suitable for the Registration in the EU as well as the USA – Different Requirements, Feasibility, Time and Cost ***
2011 Dr. Petra Regenhard Regulatory Requirements in the European Union for Avian Vaccines: Impact of the "Guideline on Data Requirements for Immunological Veterinary Medicinal Products intended for Minor Use or Minor Species/Limited Markets" on Clinical Research
2011 José Rodríguez Sánchez Switzerland: Article 13 Act on Therapeutic Products - A Review ***
2011 Christian Schlutius A step beyond module 3 of orodispersible films
  • Total: 969