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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
2003 Dr. Christof Krummeich Regulatory and pharmaceutical demands on irradiated medicinal products in Germany and Europe ***
2003 Dr. Isabel Schemainda EU Enlargement on 1 May 2004: Implications on Existing Marketing Authorizations in the Candidate Countries: Practical Aspects
2003 Dr. Cornelia Schmidt Medicines for Children, a Regulatory Target!
2003 Maren Seip Biopharmaceutics Classification System - State of the Art in Development and Practice ***
2003 Julia Tillkes Limits of "Essential Similarity" regarding abridged marketing Authorizations ***
2003 Esther Timm-Kilian Development and implementation of measures in a pharmaceutical sales company to deal with drug-related complaints ***
2003 Dr. Adriana Ivanova Vladimirova Development of generics during patent protection. Legal and regulatory framework in the EU and North America /USA and Canada/, consequence for the Candidate countries
2003 Dr. Antje Wallstab Effective Change Control Management of Product Information Texts ***
2002 Dr. Ulrike Bodesheim Review of the European variation regulation and the impact on changes in manufacturing and control of medicinal products ***
2002 Gerd Dievenich Elektronisches Rezept und elektronischer Gesundheitspass im Rahmen von Telematikentwicklungen in Gesundheitswesen
2002 Doris Göllner The organisation of a mutual recognition procedure by a pharma consulting company with Germany as RMS and all other EU member states including Norway and Iceland as CMS - experience and suggestions for practical implementation ***
2002 Birgit Haas-Heinrich Critical assessment of the stability section of an Ibuprofen sample dossier: relevance from a scientific point of view ***
2002 Dr. Stefan Hock Electronic Submissions - The German AMG-Submission Ordinance and its technical implication on the legal environment
2002 Uta Kästner Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen ***
2002 Dr. Christian Krezdorn Project Report on: Theory and Reality of Multiple Applications in National Procedure, MRP and CP Demonstrated by Practical Case Reports
2002 Dr. Hans-Jürgen Mika GMP Relating to Medicinal Products - Quality Instrument or Regulatory Burden ***
2002 Kris Pelzer Chemical-Pharmaceutical Documentation for Pressurised Metered Dose Inhalers ***
2002 Dr. Wolf-Rüdiger Schlag Analytical validation of medicinal products in contract laboratories: From the task description to an SOP for the routine analysis - an overview ***
2002 Dr. Jens Schletter Specific regulatory requirements for stem cell-based therapies ***
2002 Beate Schmidt Current regulatory requirements for clincal trials in selected EU Member States and the potential impact of the Clinical Trial Directive compared to the U.S. situation ***
  • Total: 720