Member Exclusive 2024 Webinar: Getting Your Cell Therapy Product Approved in Australia – Some Dos and Don’ts
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Presented by the ISCT ANZ Regional Executive Committee
February 9, 2024
Webinar Description:
Unlock the pathway to successful cell therapy approval in Australia with our ISCT exclusive webinar, "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts from the Therapeutic Goods Administration (TGA), this event is your guide to navigating the intricacies of regulatory processes.
Learn firsthand the crucial dos and don'ts that can make or break your cell therapy product's approval journey. Our distinguished speakers will delve into the nuanced requirements of the TGA, providing invaluable insights into crafting robust submissions, avoiding common pitfalls, and streamlining your approval process.
Stay ahead of the curve by gaining a comprehensive understanding of Australia's regulatory landscape for cell therapies. Whether you're a seasoned professional or new to the regulatory realm, this webinar equips you with practical knowledge to optimize your strategy and enhance your chances of a successful approval.
Seize this opportunity to engage directly with TGA officials, ask questions, and network with fellow industry professionals. Don't miss out! Register now for a transformative experience in advancing your cell therapy product through the regulatory maze Down Under.
Key Learning Objectives:
• Understand pathways and provisions for Cell Therapy products in Australia.
• Learn what are the regulator expectations for compliance with relevant standards
• Understand which manufacturing principles apply to cell therapies
• Learn the dos and don’ts for cell therapy dossier development
Zlatibor Velickovic, PhD (Moderator)
ISCT ANZ Regional VP, A/Prof, Director
CTTWA, Royal Perth Hospital, Australia
Jessica Sue, MSc, MHSM (Moderator)
ISCT ANZ Regional ESP Subcommittee Co-Chair, Quality Manager
Sydney Cord Blood Bank
Mat Adams, MD, PhD
Senior Evaluator
Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration, Australia
Glenn Smith, MD, PhD
Director
Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration, Australia
Tony Gill, MD
Director
Blood, Biologicals and Infectious Diseases Unit, Therapeutic Goods Administration, Australia
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