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EDQM Webinar – Advancements in gene therapy: the European Pharmacopoeia’s new approach

In response to the recent approval of many new gene therapy medicinal products (GTMPs), the European Pharmacopoeia Commission (EPC) has defined a new approach to these innovative medicinal products. This webinar will provide guidance on the two new Ph. Eur. texts that form the basis of this approach: the general chapter 5.34, ‘Additional information on gene therapy medicinal products for human use’, and the general monograph 3186, ‘Gene therapy medicinal products for human use’, which, in combination, replace and supplement the previously published general chapter 5.14, ‘Gene transfer medicinal products for human use’. The webinar will explain the links between them and other Ph. Eur. texts, highlighting the key changes versus general chapter 5.14, and explain the flexible framework of requirements necessary for these rapidly evolving products. The webinar is scheduled for 3 December 2024, 14-16:00 (CET). Please find further information including how to register and send questions in advance here.

Published on the 2nd of october 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (19 novembre 2024). EDQM Webinar – Advancements in gene therapy: the European Pharmacopoeia’s new approach. ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12ps4


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