Dear AAPS Members,
The Gene and Cell Therapy Products (GCTP) and Regulatory Sciences (RS) Communities are collaborating on an AAPS webinar "Current Understanding of Key US and European Regulatory Requirements for Gene and Cell Therapy Products with Respect to GMO and CMC"
Cell and gene therapy products continue to evolve, diversify and challenge the global regulatory frameworks for complex biological medicines. Nevertheless, the industry continues to mature and grow alongside both the skills within the industry and the knowledge of regulatory authorities, with the latter facing ever increasing demands upon their resources. However, in spite of this increase in experience and expertise within the community, and international efforts to increase regulatory harmonization, significant differences in both the legal requirements and scientific guidance for cell and gene therapy products inevitably remain between the major global markets.
When: Tuesday October 17, 2023 10:00 AM EST
For more Information and Registration: Current Understanding of Key US and European Regulatory Requirements for Gene and Cell Therapy Products with Respect to GMO and CMC | AAPS
If you would like more information, please contact @Vittal Shivva or @Raja Velagapudi and JOIN the GCTP and RS membership.
Best regards,
Steven-
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Steven Louie M.S.
Associate Director
Moderna
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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