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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
2009 Christine Kriete Peculiarities and Challenges of Herbal Medicinal Products -
Assessment of Herbal Medicinal Products within the Regulatory Environments of the European Community and the United States ***
2009 Dr. Susanne Lange The new Variation Regulation. A major step forward? ***
2009 Dr. Susanne Manhart Development of a New Active Substance for Treatment of Alzheimer’s Disease – Development from Preclinical Testing to Proof-of-Concept ***
2009 Dr. Uta Maucher Product Quality Review: New requirements related to medicinal products
2009 Dr. Nicole Max Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines – a controversial discussion ***
2009 Dr. Annette Mayer Evaluation and safety assessment of botanical preparations intended for the use in food supplements ***
2009 Dr. Stephanie Mondabon The European Commission’s "Pharmaceutical Package": An Analysis ***
2009 Dr. Christel Neiteler Classification Issues on the Borderline between Medical Devices and Medicinal Products –- Review of the Current Regulatory Discussions and Decisions ***
2009 Anna Paulina Paul The Polish Pharmaceutical Law – Strenghts and Weaknesses 5 Years after Accession to the European Union. Analysis. ***
2009 Dr. Christa Pfleiderer Regulatory Requirements for Pharmaceuticals, Biotechnological Products, and Biosimilars in Latin America: Common Requirements and Differences
2009 Dr. Maria Teresa Piccini FDA programs to expedite innovative drug development and review process: Fast Track, Priority Review and Accelerated Approval ***
2009 Dr. Agnieszka Pietas Non-Clinical and Clinical Development of Advanced Therapy Medicinal Products (ATMPs)
2009 Dr. Ulrich Reichert Implementing the Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents (EMEA/CHMP/SWP/4446/2000) ***
2009 Ralf Rickert A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU ***
2009 Dr. Marcus Riehl New provisions for the Regulation on Maximum Residue Limits ***
2009 Angela Röder Impact of the genotoxic requirements on the generic industry
2009 Dr. Birgitta Sauer Nonclinical and Clinical Requirements for the Development of an Anticancer Drug Intended for Treatment of Advanced or Late-Stage Disease - The European Perspective ***
2009 Dr. Werner Schmidt Legal Status of Donor-Lymphocyte Infusions manufactured by transiently activated Memory T cells in the context of the European Regulatory Framework
2009 Dr. Olaf Stamm Pathogen safety concepts for Biopharmaceuticals
2009 Josephine Stiebler Maintaining compliance with GRP while changing the business process aiming to be able to submit new applications in electronic format (eCTD, paperless) appropriately by end of 2009
  • Total: 968