Food and Drug
Administration
Center for Biologics
Evaluation and Research
Vaccines and Related
Biological Products Advisory Committee
Teleconference Meeting
November
20, 2008
National
Institutes of Health
Building
29B/Conference Room C
DRAFT AGENDA
Open Session
1:00 p.m. Call to Order John Modlin, M.D., Acting Chair
Administrative Matters Christine Walsh R.N., FDA
Presentation of
Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines
Research and Review, Center for Biologics Evaluation and Research
1:10 Overview of Research/Site Visit Process, Carolyn Wilson, Ph.D., FDA
Center Biologics Evaluation and Research (CBER)
1:20 Overview Office of Vaccines Research Konstantin Chumakov, Ph.D., FDA
and Review (OVRR), CBER
1:30 Overview Division of Viral Products (DVP), Jerry Weir, Ph.D., FDA
OVRR
1:40 Overview Laboratory of DNA Viruses Philip Krause, Ph.D., FDA
2:15 Q&A
2:30 Open Public Hearing (if no speakers, will move directly to closed session)
3:30 Closed Session
4:00 Adjourn Meeting