FOOD AND DRUG
ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY
COMMITTEE
MEETING ON CBER LABORATORY SITE VISITS
LABORATORY OF MYCOBACTERIAL DISEASES & CELLULAR IMMUNOLOGY
LABORATORY OF METHOD DEVELOPMENT
MEETING BY TELECONFERENCE
May
8, 2003
BUILDING 29B, CONFERENCE ROOM A
Bethesda, Maryland
1:30 PM EST
AGENDA
1:30 p.m. Call
to Order David Stephens, M.D.
VRBPAC Chair
1:35 p.m. Announcements Jody
Sachs, D.P.M.
SES Survey Results VRBPAC Exec. Sec., FDA
1:45 p.m. Open Session
Overview of Division of Bacterial,
Parasitic & Allergenic Products
Richard Walker, Ph.D.
Division Director, FDA
1:55
p.m. Overview of Division of Viral Products Jerry Weir, Ph.D.
Division Director, FDA
Laboratory of Mycobacterial Diseases & Cellular Immunology:
2:10 p.m. Overview of Research Activities Sheldon
Morris, Ph.D.
Chief LMDCI, FDA
Laboratory of Method Development:
2:20 p.m. Overview of Research Activities Konstantin
Chumakov, Ph.D.
Chief LMD, FDA
2:30 p.m. Open
Public Hearing
3:30 p.m. Closed
Session
Discussion and Committee
Recommendations
4:00 p.m. Adjournment