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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
2004 Heike Strutzenberger The regulatory requirements of EU-Directive 2001/20/EC and transposition into national legislation of the Member States
2004 Verena Stumpf Switch from CFC-containing to CFC-free metered dose inhalers - current status and regulatory aspects ***
2003 Dr. Robert Alz Antimicrobial Drug Resistance - Impact on the Pre- and Postlicensing Process of Veterinary Medicinal Products in the European Community
2003 Sandra Baghestani, geb. Strohhöfer Generic applications in the EU and in the USA - a comparison ***
2003 Dr. Christine Bautz The legal status of medicinal products: Potential problems arising in case of a compulsory harmonisation as discussed in the current revision of the EU legislation ***
2003 Dr. Michael Berntgen Exploring Paediatric Indications for Off-patent Drug Substances - Strategic Input of Regulatory Affairs ***
2003 Loneliese Canali The different regulatory requirements for conducting clinical trials in the EU and the consequences for multinational studies. How will these procedures be changed by implementation of the Clinical Trial Directive 2001/20/EC? ***
2003 Leonor Enes A comparative study of generic medicinal products in Europe ***
2003 Veronika Etges CMC - Variation in a Globally Operating Pharmaceutical Company ***
2003 Dr. Kirsten Hiebenthal-Millow Test procedures in the specifications for herbal medicinal products according to CPMP / CVMP-guidelines compared with those for chemically defined medicinal products ***
2003 Dr. Beate Hötzl Biotechnological generics - a matter of science or science fiction? ***
2003 Claudia Koritke Essential Aspects of Quality Assurance in Outsourcing Production and Purchase of Active Pharmaceutical Ingredients
2003 Rika Kremmer Regulatory Enviroment for Traditional Herbal Medicinal Products in the European Union ***
2003 Dr. Roland Kröger Pharmacovigilance Critical Assessment of Current Regulatory Issues with Special Regard to Urgent Safety Restrictions ***
2003 Dr. Christof Krummeich Regulatory and pharmaceutical demands on irradiated medicinal products in Germany and Europe ***
2003 Dr. Ursula Malter Regulatory Requirements for Generic Applications within the EU – Chemically Defined Drugs versus Biotechnology-Derived Products ***
2003 Dr. Anja Mecklenburg Strategies for Carcinogenicity Testing of Human Pharmaceuticals ***
2003 Heike Mödinger Variation Procedures of Marketing Authorisations Granted via MRP versus Marketing Authorisations Granted According to National Law in German Speaking Countries (Germany, Austria, Switzerland) Comparison and Discussion of Advantages and Disadvantages ***
2003 Birgit Moetamedi Comparison and assessment of the current EU-Variation Regulations 541/95 and 542/95 and the revised new EU-Variation Regulations 1084/2003 and 1085/2003 ***
2003 Michael Riesenberger Legal and regulatory aspects of manufacturing, quality control and release of 2-[18F]Fluro-2-desoxyglucose ([18F]-FDG) as an example for short-lived radiopharmaceuticals in reflection of relevant regulations, directives and guidelines ***
  • Total: 969