DRAFT AGENDA (revised 01/10/02)


Joint meeting of the



and the


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