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Event

Hot Topic Discussion with FDA: Cold-Stored Platelets (23EL-896) – Free for AABB Individual Members!

Please note: AABB reserves the right to make updates to this program.

Thursday, December 14, 2023
12:00 - 1:00 PM Eastern Time
Program Number: 23EL-896

Registration

This Hot Topic Discussion is provided complimentary to AABB individual members; nonmembers to pay regular rate of $69. Registration includes access to both the live and on-demand version of this hot topic discussion. Group viewing/registration is not available/provided. Access instructions for the live program will be provided via email approximately 48-72 hours after registration. An automated email from customercare@gotowebinar.com will provide access information unique to each registrant (check your spam or junk email folders if you do not receive it; add customercare@gotowebinar.com to your safe sender list (this email address is not monitored). The program will be hosted on GoToWebinar so please take a moment prior to the live program to perform a System Check for GoToWebinar.

Please note: registration for the live program will close one (1) hour prior to the program start time. If you register after this time, you will receive access to the on-demand hot topic discussion when it is available.

If you would like to receive this program for free as well as other great benefits, consider joining AABB today.

  • Program Description

    Join the Food and Drug Administration for a Hot Topic Discussion on cold-stored platelets (CSPs). In this program, representatives from FDA will answer questions and discuss considerations and concerns related to cold-stored platelets and the agency’s June 2023 guidance, “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.” The program will also focus on the regulatory history and rationale for cold-stored platelet components and describe the available evidence for their use in the treatment of active bleeding.

    The FDA will respond to the most frequently asked questions upfront.

    Learning Objectives

    After participating in this educational activity, participants should be able to:

    • Summarize the regulatory history and rationale for cold storage of platelet components.
    • Describe the available evidence for use of cold stored platelets (CSP) in the treatment of active bleeding, including in vitro studies, clinical studies, and knowledge gaps.
    • Apply the recommendations in the June 2023 FDA guidance on alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical.

    Program Faculty

    Moderator: Sharon Carayiannis, MT(ASCP)HP, Vice President, Accreditation, Standards & Quality, AABB
    Speakers:

    • Anne Eder, MD, PhD, Acting Director, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration
    • Carlos Villa, MD, PhD, Associate Director of Special Projects, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration

    Continuing Education Credit

    This activity is eligible for one (1) continuing education credit/contact hour for California-based nursing professionals, California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number and type of credits granted for this program (live or on-demand) based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage. Please note: this program is not eligible for continuing medical education credit for physicians.

    Register