SUMMARY

On November 8 & 9, 2017 the Food and Drug Administration (FDA) is conducting a public workshop entitled “Immune Globulin Potency in the 21st Century.”  The purpose of the public workshop is to discuss new challenges for Industry to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address these challenges.  The workshop has been planned in partnership with the Immune Deficiency Foundation (IDF) and the Plasma Protein Therapeutics Association (PPTA). The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.

The workshop will include presentations and panel discussions on the following topics:

(1) The history and rationale for measles and polio antibody potency assays for IG products; (2) decreased measles antibody levels in plasma donors and IG products over time, and impact of donor revaccination to increase measles antibody levels; (3) potential effects of diminishing measles titers in IG products on Immune Deficiency patients and on IG supply; (4) effect of polio eradication on availability of polio virus for potency assays, and alternative assays for polio antibodies; and (5) identification of potential  replacement potency tests for IG products.

DATES:

November 8, 2017, 8:00 AM – 5:00 PM
November 9, 2017, 8:30 AM – 12:00 PM

LOCATION:

National Institute of Allergy and Infectious Diseases (NIAID)
5601 Fishers Lane
Rockville, MD 20892

Entry into the facility includes routine security check procedures.  Please visit the following Web site for NIAID campus location, parking, security, and travel information https://www.niaid.nih.gov/about/visitor-information

REGISTRATION:

To register for the public workshop, please visit the following Web site: https://www.eventbrite.com/e/immune-globulin-potency-in-the-21st-century-workshop-registration-36363733907.  Persons interested in attending this public workshop must register by October 25, 2017.  Early registration is recommended because seating is limited.  If time and space permit, onsite registration on the day of the public workshop will be provided starting at 7:00 AM. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. 
 
If you need special accommodations due to a disability, please contact Heather Lilley or Sherri Revell by email send to [email protected] at least 7 days in advance. 
Contact Persons:  Sherri Revell or Heather Lilley. For questions, email [email protected] (Subject line: Immune Globulin Potency in the 21st Century).
Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov  A link to the transcript will also be available on the internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm568419.htm. 
 

Resources For You

• Draft Immune Globulin Potency in the 21st Century
• Immune Globulin Potency In The 21st Century - Wednesday, November 8, 2017
• Immune Globulin Potency In The 21st Century - Thursday, November 9, 2017