Contributing to FDA’s Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT)
Wednesday, May 29, 2024 02:15 PM - 03:15 PM
Room 205-207
Regulation & Policy
Roundtable
Organized by: U.S. Food and Drugs Administration (FDA) & ISCT North America Legal & Regulatory Affairs Committee
Moderator
Discuss how the program will be implemented and participate in the standards development process.
Key Learning Objectives
1. Introduce the Standards Recognition Program for Regenerative Medicine in the USA
2. Understand the value of standards in product research and development.
3. Understand how standards can be used by regulators in assessing regenerative medicine products.
Moderator
- Judith Arcidiacono, MS, Food and Drug Administration (FDA), United States
- Archana Siddam, PhD, Food and Drug Administration (FDA), United States
- Dawn Henke, PhD, Standards Coordinating Body (SCB), United States
- Sumona Sarkar, PhD, National Institute for Standards and Technology (NIST), United States
Discuss how the program will be implemented and participate in the standards development process.
Key Learning Objectives
1. Introduce the Standards Recognition Program for Regenerative Medicine in the USA
2. Understand the value of standards in product research and development.
3. Understand how standards can be used by regulators in assessing regenerative medicine products.