| 2025 |
Dr. Anissa Boucherot |
Strategies and Measures to Prevent Substandard and Falsified Medicinal Products in Sub-Saharan Africa *** |
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| 2025 |
Robert Crispien |
The accomplishments of ISO IDMP implementation and the requirement of further adaption in NCAs using the example of BfArM |
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| 2025 |
Sarah Gieseler |
Potential impact of optimisation proposals for the revision of the regulatory framework for variations |
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| 2025 |
Kathleen Grundke |
The Modernization of the US Cosmetic Regulation Act of 2022: An Overview of the New Challenges for Small and Medium Enterprises in the USA *** |
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| 2025 |
Maria Krach |
Das Medizinforschungsgesetz: Auswirkungen auf den Studienstandort Deutschland im Hinblick auf Novartis-spezifische Studien *** |
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| 2025 |
Zhivko Krokodilov |
Regulatory grade RWD/RWE data quality for drug discovery and development |
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| 2025 |
Stefan Läer |
Chancen und Risiken aktueller Entwicklungen der Arzneimittelzulassung mit Blick auf HMPC-Monographien |
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| 2025 |
Yaofang Li |
A Comparative Analysis of Biosimilars Requirements in the EU, the US, and China: Commonalities, Differences, Case Studies and the Global Development Strategy |
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| 2025 |
Dr. Wenrui Liu |
China's Regulatory Framework for Companion Diagnostics: A Focused Comparison of Key Aspects with the US and EU |
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| 2025 |
Ivan Makhnusha |
Harmonizing Storage Conditions for Pharmaceuticals: Implication and Challenges in Drug Storage throughout the Life Cycle in Compliance with Stability Guidelines |
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| 2025 |
Dr. Pawel Masiewicz |
Discussion of regulatory requirements for DNA starting material used for the manufacture of mRNA and gene therapy medicinal products *** |
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| 2025 |
André Pukowski |
An Assessment of Regulatory Measures to Combat Drug Shortages. A Comparison of the Existing FDA System With the New EU System to be Introduced as Part of the ”Pharma Package” |
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| 2025 |
Judith Rechler |
Post-Authorisation Implementation of a New Finished Product Manufacturer - A Case Study Analysis *** |
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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 |
Sabrina Yamoune |
Herausforderungen in der Zulassung und Herstellung von CAR-T-Zelltherapien: Einblicke aus klinischer Perspektive |
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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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