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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
2021 Anna Rubik Drug Shortage - A complex global challenge. Recent developments in the EU, industrial aspects with a special focus on Austria and an idea of international handling via a global portal ***
2021 Dr. Alex Savtschenko Preclinical toxicity profiles of authorised medicinal products: analysis and comparison between short-term and long-term repeated dose toxicity studies in animals ***
2021 Dr. Ramsi Siaj The New ICH-Guideline S11 on Nonclinical Safety Testing - Opportunities and Challenges for Overall Development of Paediatric Medicine ***
2021 Dr. David Thalmann New Dosage Forms of Old Substances - Regulatory Strategies and Challenges in the European Union ***
2021 Dr. Sara Tognarelli Between flexibility and standardization: the challenge of the first European Pharmacopoeia individual monograph for monoclonal antibodies. The case study of the monograph 2928 "Infliximab concentrated solution"
2021 Sandra Walkowiak Fast and Simplified Procedures for Herbal Medicinal Products in Pacific Alliance Countries
2021 Lucy Weinreich Der besondere Bedarf an nicht zugelassenen Arzneimitteln - Nationale Regelungen in Österreich und Deutschland mit Fokus auf den deutschen Einzelimport gem. § 73 Abs. 3 AMG ***
2020 Elizabeth Abari Decentralized trials - A survey of the regulatory and ethical environment when studies no longer take place in a traditional way
2020 Dr. Hamza Al-Tamari The European Commission's Proposed Regulation on Health Technology Assessment–Background, Challenges, and Opportunities ***
2020 Dr. Caroline Alba Import, Export, Storage and Distribution of Controlled Drugs - Regulations in UK, France, Germany ***
2020 Mohamed Amer Regulatory Affairs in Egypt
2020 Dr. Poonam Balani Regulatory requirements and actual data outcomes from EPARs on the Non-clinical Studies of ATMPs (Covering Gene Therapy, Somatic Cell Therapy), and Recombinant Proteins other than Monoclonal Antibodies based on Review of EPARs (12/2009-12/2019) ***
2020 Dr. Katja Bendrin Regulatory Strategies for Promoting the Safe Use of Prescription Opioids and the Potential Impact of Overregulation ***
2020 Dr. Martin Bommer The Role of Academia in Driving Post-Approval Innovation in Areas of Unmet Medical Need ***
2020 Britta Dauber Pharmacovigilance Obligations in the Pharmaceutical Company for Homeopathic- and Traditional Herbal Medicinal Products - Transposition of Directive 2001/83/EC into the German Medicinal Product Act - AMG
2020 Alexander Dziambor Harmonisation of the Quality Dossier by Means of the Worksharing Procedure: A Look at Execution and Advocacy from Applicant's Perspective ***
2020 Sandra Eikermann Opportunities for simplified registration of herbal medicinal products with limited clinical data in selected Non-EU countries ***
2020 Cornelia Erhard Access Consortium - New Active Substance Work-Sharing Initiative
2020 Sarah Safaa Essmat Thalidomide catastrophe: its impact on the design and assessment of toxicological experiments and its current regulatory recommendations
2020 Uwe Faude New Requirements and Legal Framework for Orphan Drug Medicinal Products with Conditional Marketing Authorization for Data Generation according to the "Gesetz für mehr Sicherheit in der Arzneimittelversorgung" (GSAV – Law for more Security in Drug Supply) in Germany
  • Total: 967