Presentations

Live Session: Raising the bar on commercial products to have GMP materials in the COVID-19 era

Wednesday, January 27, 2021 - 17:00 to 18:00
Advanced Therapies Connect 2021 - Phacilitate's 2nd Virtual Experience - WATCH

Introduction

This session will answer:
  • How is a strong, fluid and robust supply chain for ancillary materials critical to the manufacture of commercial products?
  • Can manufacturers afford to produce commercial products with subpar ancillary materials?
  • How does the quality of ancillary materials impact emerging cell and gene therapy products?
  • Why is the submission of DMF in eCTD format now a requirement?

Related Information

Speakers

Laurie Norwood
Regulatory Consultant - Akron Biotech
Claudia Zylberberg
Founder and Chief Executive Officer - Akron Biotech
Vijayan Nair
Senior Director Special Projects, Octapharma
Mark Bonyhadi
Senior Advisor - Qiming Venture Partners USA
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