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 have been incorporated in European Pharmacopoeia (Ph. Eur.) Supplement 11.7 to be implemented as of 1 April 2025. 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.
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This webinar guides the participants through the two new Ph. Eur. texts. It explains the links between them and other Ph. Eur. texts, highlighting the key changes versus general chapter 5.14, and explains the flexible framework of requirements, necessary for these rapidly evolving products.
Target audience
This webinar is of interest to professionals working in the development, manufacture, quality control, quality assurance and licencing of GTMPs.
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Duration: 1 hour, 28 minutes
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