Advancements in gene therapy: the European Pharmacopoeia’s new approach
Several gene therapy medicinal products (GTMPs) have been approved in recent years and it appears likely that ongoing clinical trials will result in more reaching the market. The European Pharmacopoeia Commission (EPC) has responded by defining a new approach to these promising and innovative medicinal products. At its 178th Session in March 2024, the EPC replaced the general chapter, Gene transfer medicinal products for human use (5.14), with a general monograph, Gene therapy medicinal products for human use (3186), and an accompanying chapter, Additional information on gene therapy medicinal products for human use (5.34). These changes will be incorporated in European Pharmacopoeia (Ph. Eur.) Supplement 11.7 to be implemented as of 1 April 2025 (published in October 2024). The new monograph outlines requirements for GTMPs, including genetically modified autologous cells, adeno-associated virus vectors and oncolytic herpes simplex virus. Overall, this marks a significant step toward standardised control of GTMPs.
More information HERE.
This webinar will guide the participants through the two new Ph. Eur. texts. 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. Lastly, participants will be able to submit their questions in advance and interact with the presenters through live polling and a Q&A session.
The webinar will take place on 03 December 2024, from 14:00 to 16:00 (CET, Paris, France).
Send us your questions in advance
Registered webinar participants are invited to submit their questions in advance using the online question form. It will also be possible to send us questions during the webinar but submitting them in advance will help us focus on the topics that generate the most interest. We cannot promise to answer every question, but all questions are welcome and encouraged.
If you would like to submit a question in advance, please complete the online question form and clik on "Submit". For organisational reasons, these questions should be submitted no later than 29 November.
This webinar will be of interest to professionals working in the development, manufacture, quality control, quality assurance and licencing of GTMPs.
Participation is free of charge.
This webinar is free of charge.
Places are limited, so sign up today!
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