FALLS CHURCH, Va., July 8, 2020 /PRNewswire-PRWeb/ -- Overcoming Comparability Issues in Regenerative Medicines Manufacturing: The Latest on Cell and Gene Therapy Regulation An FDAnews Webinar Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/cellandgenetherapy
A product may need a comparability study, but what is the most effective way to complete one? Will the study comply with all FDA requirements? Understanding how to meet the expectations of this task is critical for anyone creating and manufacturing these therapies.
While the natural evolutions of a therapy may have improved it, the shifts risk its critical quality attributes, or CQAs. Comparability studies mitigate those risks and allow one to retain those CQAs. An effective study will match the level of changes, with stricter comparability needed as greater adjustments accumulate.
During this FDAnews webinar, attendees will learn the most effective ways to navigate the process and meet FDA expectations. Scott R. Burger, MD and principal of Advanced Cell and Gene Therapy, will share practical tips and guidelines around determining the level of a comparability study, planning and preparing for an analysis, and avoiding common mistakes before FDA interactions:
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.
Webinar Details: Overcoming Comparability Issues in Regenerative Medicines Manufacturing: The Latest on Cell and Gene Therapy Regulation An FDAnews Webinar Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT https://www.fdanews.com/cellandgenetherapy
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/cellandgenetherapy By phone: 888.838.5578 or 703.538.7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
SOURCE FDAnews
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A product may need a comparability study, but what is the most effective way to complete one? Will the study comply with all FDA requirements? Understanding how to meet the expectations of this task is critical for anyone creating and manufacturing these therapies.
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While the natural evolutions of a therapy may have improved it, the shifts risk its critical quality attributes, or CQAs. Comparability studies mitigate those risks and allow one to retain those CQAs. An effective study will match the level of changes, with stricter comparability needed as greater adjustments accumulate.
During this FDAnews webinar, attendees will learn the most effective ways to navigate the process and meet FDA expectations. Scott R. Burger, MD and principal of Advanced Cell and Gene Therapy, will share practical tips and guidelines around determining the level of a comparability study, planning and preparing for an analysis, and avoiding common mistakes before FDA interactions:
- FDA Requirements for Comparability Studies
- Risk Analysis and Mitigation
- Designing an Effective Comparability Protocol
- Statistical Comparability Approaches
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.
Webinar Details: Overcoming Comparability Issues in Regenerative Medicines Manufacturing: The Latest on Cell and Gene Therapy Regulation An FDAnews Webinar Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT https://www.fdanews.com/cellandgenetherapy
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/cellandgenetherapy By phone: 888.838.5578 or 703.538.7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
SOURCE FDAnews
