Dear RS and GCTP Community 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
Oct 17th is only couple days away. Please block your calendar from 10 to 11:30 am just to focus on this Webinar. Steven Louie from GCTP community posted this before but am posting again to bring to your attention. It may be a good learning opportunity for RS and GCTP/CMC communities. Thanks to GCTP community for their cross community collaboration and putting this webinar together.
-Raja Velagapudi
Chair, RS Community
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Raja Velagapudi Ph.D.
Sr. Director, Clinical Development
Tolmar Inc
Monmouth Junction NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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