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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 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
2011 Dr. Saskia Siewert Implementation of Quality by Design in the Pharmaceutical Development of semisolid topical drug products ***
2011 Dr. Liane Söllner The need for juvenile animal studies - a critical review ***
2011 Sebastian Strobl Counterfeit drugs in industrialized and developing countries - A comparison ***
2011 Dr. Verena Tautorat The end of an era: Implementing Variation Directive 2009/53/EC into German Drug Law ***
2011 Dr. Franz Thannberger A Step beyond Module 3 of "passive" Transdermal Therapeutic Systems ***
2011 Anja Then-Kania Postapproval CMC Changes in the United States with a Focus on Biopharmaceuticals - Current Status and an Outlook in the Pharmaceutical Development ***
2011 Kristina Tripp Case Study: Impact of a new German law ("AMNOG") to restructure the pharmaceutical market on a Generic Company
2011 Dr. Alexander Vuia First revision of the "Guideline on the Investigation of bioequivalence": BCS-based Biowaiver - opportunities and limitations
2011 Dr. Bettina Walter-Lorenzen Improvement of the workflow, quality and effective management of product information texts using a new database
2011 Dr. Günter Waxenecker The "Risk Based Approach" - an important tool for managing all the duties in Drug Regulatory Affairs ***
  • Total: 959