The European Directorate for the Quality of Medicines & HealthCare (EDQM) will hold a free webinar entitled “Advancements in gene therapy: the European Pharmacopoeia’s new approach” on 3 December 2024, from 14:00 to 16:00 (CET, Paris, France).
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 promising and innovative medicinal products. This webinar will guide the participants through two new Ph. Eur. texts that form the basis of this approach: the general chapter Additional information on gene therapy medicinal products for human use (5.34) and the general monograph Gene therapy medicinal products for human use (3186) which, in combination, replace and supplement the previously published general chapter, Gene transfer medicinal products for human use (5.14). It 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.
Send us your questions in advance
As a registered participant, you can submit your questions in advance using the online question form until 29 November 2024 (23:59 CET, Paris, France). During the webinar, you will be able to interact with the presenters through live polling and a Q&A session. While it will be possible to send in questions during the webinar, submitting them in advance will help us tailor the content to focus on topics that generate the most interest.
Full information on the webinar can be found on the dedicated event web page: Advancements in gene therapy: the European Pharmacopoeia’s new approach.
Click here for more information on the new European Pharmacopoeia Commission approach to gene therapy.
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