Dawn Henke

Company: Standards Coordinating Body

Job title: Executive Director

Seminars:

Understanding Which Guidance to Adhere to & Leveraging FDARecognized Standards for Raw Materials in Cell & Gene Therapies 9:45 am

Discussing the current standards under development for raw materials in cell and gene therapy Which resources can be used for implementing new standards for raw materials Positioning your organization for future regulatory expectations and standardization trendsRead more

day: Conference Day One

Panel Discussion: Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development 9:10 am

Firsthand experience contributing to a new ISO standard, focused on ancillary materials used in advanced therapies Overview of the U.S. TAG validation process and transition to a New Work Item Proposal within the ISO framework What this upcoming standard means for developers, manufacturers, and regulators over the next 3 to 4 yearsRead more

day: Conference Day Two