DRAFT AGENDA (revised 01/10/02)
FOOD AND DRUG ADMINISTRATION
Joint meeting of the
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
and the
BLOOD PRODUCTS ADVISORY COMMITTEE
Holiday Inn
Versailles Ballrooms I & II
Bethesda, Maryland 20814
January 17, 2002
Thursday January 17, 2002, OPEN SESSION
8:00 a.m. Administrative Remarks, William Freas, PhD, Executive Secretary
8:05 Presentation of Certificates
8:10 Opening remarks - David Bolton, PhD, Committee Chairman
Committee Update
8:15 Revised FDA Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products: Final Guidance - Dorothy Scott, MD (OBRR, CBER, FDA)
8:45 Open Public Hearing
Committee Update
9:15 PPTA presentations on clearance of spiked TSE infectivity and protease-resistant prion proteins by plasma processing
To be assigned (Aventis Behring)
Douglas Lee, PhD (Bayer Corporation, Research Triangle Park, NC)
To be assigned (PPTA)
10:15 Break
Thursday January 17, 2002, OPEN SESSION (Continued)
Topic #1: Effectiveness of measures taken to protect humans from food-borne exposure to the BSE agent in countries with BSE: Implications for vCJD risk and blood safety
10:30 Introduction, background, charge and questions
David M. Asher, MD (OBRR, CBER, FDA)
10:50 Variant CJD in the UK: Update and review of recent epidemiological studies
Hester Ward, MD (CJD Surveillance Unit and Western General Hospital, Edinburgh, UK)
11:30 BSE and human food chain protective measures in the UK
Peter Soul, DVM (DEFRA, London, UK)
12:10 Efforts and needs for global control of BSE and vCJD: A view from the WHO
Maura Ricketts, MD (WHO, Geneva, Switzerland)
12:40 Lunch break
1:40 Open Public Hearing
2:10 Committee discussion
2:30 Questions to the Committees
3:00 Committee update
Harvard BSE Risk Assessment: Summary and update
George M. Gray, PhD and Joshua Cohen, PhD (Center for Risk Analysis, Harvard School of Public Health, Boston)
4:00 Questions from the Committees to presenters
4:30 Adjourn