| 2025 |
Dr. Alessandra Bierwagen |
Theranostic Radiopharmaceuticals: A Clinical View on the Approaches to Marketing Approval in the EU and the US *** |
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| 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 |
Verena Daniel |
Darreichungsformen für medizinisches Cannabis - Globale Entwicklungen, pharmazeutisch-medizinische Bewertung und regulatorische Einordnung *** |
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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 |
Jan-Oliver Kahl |
Regulatory Evaluation of AI-Generated Dossier Parts with the Focus on Module 2.3 *** |
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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. 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 |
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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