| 2025 |
Judith Rechler |
Post-Authorisation Implementation of a New Finished Product Manufacturer - A Case Study Analysis |
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| 2025 |
Dr. Esther Schwich |
Die Problematik der Abgrenzung von Arzneimitteln und Medizinprodukten - Die pharmakologische Wirkung als Schlüssel zur Abgrenzung? |
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| 2025 |
Dr. Anna Seydel |
Comparison of veterinary pharmacovigilance in the European Union under Directive 2001/82/EC versus under Regulation (EU) 2019/6 with a focus on the administrative burden for MAHs before, during, and after implementation of Regulation (EU) 2019/6 |
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| 2025 |
Dr. Felix Spenkuch |
Analyzing the Global Implementation Efforts of the ISO Identification of Medicinal Products Standard - What is needed for consistent Progress? |
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| 2025 |
Carina Uhe |
Comparative Analysis of Sustainability Requirements for Medicinal Products: A Transatlantic Perspective between the European Union and the United States |
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| 2025 |
Marvin Witt |
Auswirkungen der EU-Fluorgas-Verordnung (EU) 2024/573 auf Drug Regulatory Affairs: Eine Analyse der regulatorischen Anforderungen und deren Folgen für Umwelt, Arzneimittelversorgung und Patientensicherheit |
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| 2025 |
Sabrina Yamoune |
Herausforderungen in der Zulassung und Herstellung von CAR-T-Zelltherapien: Einblicke aus klinischer Perspektive |
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| 2025 |
Gizem Yüce |
Project Orbis - A Comprehensive Overview and its Global Impact on the Regulatory Industry, with Special Emphasis on Swissmedic |
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| 2024 |
Maria Berlenbach |
How Good Manufacturing Practice (GMP) auditing impacts the quality part of the registration dossier for Active Pharmaceutical Ingredients |
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| 2024 |
Katharina Dupont |
Risk minimisation measures in the pharmaceutical industry – a review of the handling of Direct Healthcare Professional Communication (DHPC) and Educational Material (EM) in Germany, Austria and Switzerland |
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| 2024 |
Berit Frei |
A review of the regulatory framework for Drug-Device Combination Products in Europe and the implications of the Medical Device Regulation (EU) 2017/745 implementation |
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| 2024 |
Dr. Martina Hänsel |
Das Gender Health Gap in der Arzneimittelforschung und bei der Arzneimittelzulassung innerhalb der Europäischen Union – Spiegelt sich eine Berücksichtigung von geschlechtsspezifischen Unterschieden in den regulatorischen Rahmenbedingungen und in den Produktinformationen wider? Eine Betrachtung anhand der Beispiel-Indikationen Rheumatoide Arthritis (RA) (2017 - 2024) und COVID-19 (2020 - 2024) |
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| 2024 |
Khaled Hatem |
Towards Harmonised Medicine Regulation in Africa: Analysing the Feasibility of Adopting the Centralised Procedure of the European Medicines Agency for the African Medicines Agency |
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| 2024 |
Dr. Jana Heidemann |
Pharmaceutical regulatory landscape in the United Kingdom after the Brexit and current regulatory changes, with focus on the Windsor Framework and the International Recognition Procedure |
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| 2024 |
Kevin Hohl |
Nitrosamine Risk Management for Medicinal Products: WHO's Role and a Case Study of Camzyos® |
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| 2024 |
Dr. Tobias Jaud |
The maze of extractables and leachables - Regulatory risk assessment of β-Glucans |
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| 2024 |
Jessica Jeschke |
Regulatory and Scientific Strategies to Combat Antimicrobial Resistance in the EU |
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| 2024 |
Eva Kreßner |
Finding a balance between the need for comprehensive transparency in clinical trials and the protection of commercially confidential information in today’s regulatory environment |
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| 2024 |
Dr. Sabine Küppers |
Development of Tissue Engineered Products in the EU - Will the European Commission’s and EMA's Action Plan on Advanced Therapy Medicinal Products make the difference? |
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| 2024 |
Michael Link |
Comparative Analysis of Evaluation and Reimbursement Pathways for Digital Health Applications in Germany, France, and Belgium - Current Status and Outlook for the EU |
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