Dawn Henke

Company: Standards Coordinating Body

Job title: Executive Director

Seminars:

Panel Discussion: Delving into the Regulatory Frameworks Governing the Use of Raw & Starting Materials, Including GMPs & Exploring Strategies to Achieve Compliance 3:15 pm

Navigating current regulatory guidance on biological raw materials for ensuring approvals in all regions Discussing regulator’s expectation on translating from research to the clinic with proprietary materials to ensure patient safety and clinical approval Discussion on areas of future policy for cell and gene therapy raw and starting materials to accelerate development of safe, scalable…Read more

day: Conference Day 2

FDA Recognized Standards for Raw Materials in Regenerative Medicine Therapies 9:00 am

The FDA standards recognition program for regenerative medicine therapies Current standards under development for raw materials Resources for implementing standards for raw materialsRead more

day: Conference Day 1