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Session Details

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
  • Judith Arcidiacono, MS, Food and Drug Administration (FDA), United States
Panelists:
  • 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. 

Sumona Sarkar
Biomedical Engineer
National Institute of Standards and Technology
Panelist


Archana Siddam
Biologist
FDA
Panelist


Judith Arcidiacono
International Regulatory EXPERT
FDA/CBER
Moderator


Dawn HENKE
Executive Director
Standards Coordinating Body
Panelist