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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
2016 Mariana Lagos Quintana Oligonucleotide-based Therapeutics, Development and Regulatory Challenges ***
2016 Katrin Lambrecht Pyrrolizidine alkaloids - Impact of the public statements made by EMA and national health authorities on the pharmaceutical industry ***
2016 Martina Luh Data integrity: Presentation of Measuring values in Module 3: Challenges for Regulatory CMC
2016 Dr. Julia Katharina Mack Revision of Council Directive 90/167/EEC – current and future legal situation regarding medicated feed in the European Union as compared to the United States of America and Canada ***
2016 Dr. Qian Mao Breakthrough Therapy Designation: Challenges and Opportunities for Innovative Drug Development – A Three-Year Review after PDUFA V ***
2016 Juliane Merz Investigation on Melatonin as a Substance: A Closer Consideration of Differences and Similarities in the Legal Principles Applicable to Melatonin Containing Products at the International, European and National Level - Including a potential regulatory strategy to obtain a marketing authorisation for Germany
2016 Christiane Metje Benefits and success of outsourcing in DRA
2016 Dr. Caroline Mörler Produktinformationen in Deutschland: Welche europäischen sowie nationalen Verfahren und gesetzlichen Vorgaben nehmen Einfluss auf die Gestaltung von Fach- und Gebrauchsinformationen - eine Übersichtsarbeit
2016 Dr. Robert Mühlbacher Diversity of regulatory requirements for the approval of biosimilars in the LATAM region: Comparison of the WHO guidance with the available guidelines/regulations in Chile, Brazil and Colombia ***
2016 Kathrin Mundt National piloting activities in preparation of the new Clinical Trials Regulation Regulation (EU) No 536/2014 ***
2016 Dr. Francois-Xavier Orveillon Status, challenges and regulatory framework for the development and registration of virus vectored vaccines in Europe
2016 Dr. Julian Paesler Contraception in adolescents - regulatory considerations ***
2016 Dr. Andrea Rohrauer-Scherr Benefit Assessment and Indication in Marketing Authorisation - Relevance for and Impact on Paediatric Research, Pricing, Reimbursement, Medical Therapy and Advertising ***
2016 Gianluca Ronzoni Technical Regulatory change assessments for worldwide approved medicinal products - complexities in a regulatory non-harmonized and dynamically evolving environment
2016 Ellen Scheibe The issue of extrapolation of indications in the registration of biosimilars ***
2016 Dr. Brita Schulze Different Salts of a Drug Substance - Comparison of Regulatory Pathways in the EU and USA ***
2016 Dr. Volker Spehr Virulence factor inhibition, a novel approach to treat life-threatening bacterial infections: Challenges for industry, legislation, and agencies ***
2016 Till Teschke Changes in the regulatory assessment of manufacturing process validation ***
2016 Anna Touhidi The Double Edged Regulation of Liquid Chemical Germicides Used in Healthcare Settings. The Burden of a Joint Jurisdiction, Demarcation of Categories and Regulatory Requirements in the United States of America ***
2016 Dr. Michael Türck Regulatory and Practical Consequences of the New Clinical Trial Regulation (EU) No 536/2014 for the Clinical Trial Application Processes of Pharmaceutical Companies and CROs ***
  • Total: 969