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May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Final Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee Meeting
May 7, 2010
Hilton Hotel, Gaithersburg, MD
AGENDA

 

Open Session

 

Topic 1: Finding of PCV DNA Sequences in Rotavirus Vaccines

8:00 a.m.Call to Order and Opening Remarks
Conflict of Interest Statement 
Jack Stapleton, M.D., Chair
Christine Walsh, R.N., FDA
8:10FDA Introduction/Presentation of
Issues for Discussion 
Norman W. Baylor, Ph.D., FDA
8:20FDA Safety Update for Rotavirus VaccineDavid Martin, M.D. M.P.H., FDA
8:30 Update on Rotavirus Disease and the Impact
of Rotavirus Vaccines
Umesh Parashar, M.D., M.P.H., CDC
8:45GSK Assessment of PCVBarbara Howe, M.D.
X.J. Meng, M.D., Ph.D.
Emmanuel Hanon, Ph.D.
Gary Dubin, M.D.
Leonard Friedland, M.D.
9:45Porcine Circovirus: An OverviewGordon Allan, Ph.D., Queen’s
University Belfast
10:05Break 
10:20CBER Assessment of PCVPhil Krause, M.D., FDA
11:00Open Public Hearing 
11:30Committee Discussion:  PCV1 in Rotarix 
12:30 p.m.Lunch 

Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee Meeting
May 7, 2010
Hilton Hotel, Gaithersburg, MD


AGENDA

 

Open Session

 

Topic 2:  Advanced Analytical Methods in the Characterization of Cell Substrates

1:30Characterization of Cell Substrates Used
in the Production of Viral Vaccines
for Human Use and Summary of New
Technologies
Keith Peden, Ph.D., FDA
2:15Open Public Hearing 
2:45Committee Discussion 
4:30Adjourn Meeting