Run time: 60m

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2020 AABB Annual Meeting On-Demand

AM20-33: COVID-19 Convalescent Plasma (CCP) -- The Regulatory Landscape


Oct 5, 2020 10:00am ‐ Oct 5, 2020 11:00am


Expiration Date: Dec 31, 2022


Credits: None available.

Standard: $25.00
Members: $20.00

Description

During this live Q&A session, FDA’s Peter Marks and Nicole Verdun will answer questions about the regulatory framework for COVID-19 Convalescent Plasma (CCP). We will be taking live questions during the session and will try to get to as many of them as possible. 

Topics for discussion include:

- Timeline for implementation of the EUA.
- FDA’s use of temporary enforcement discretion .
- An update on the testing and labeling collections as high-titer or low-titer.
- Inventory management options such as retesting units collected under the National Expanded Access 

Program for use under the EUA or for shipment to the Surge Capacity Storage

Learning Objectives:
  • Review current regulatory process for CCP
  • Describe current regulations regarding CCP
  • Describe current regulatory landscape for CCP

Speaker(s):

  • Dr. Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
  • Dr. Nicole Verdun, MD, Director, Office of Blood Research and Review, FDA

Disclosures

  • Peter Marks, MD, PhD : Nothing to disclose
  • Nicole Verdun, MD : Nothing to disclose

Credits Available


AM20-33: COVID-19 Convalescent Plasma (CCP) -- The Regulatory Landscape Evaluation

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