Office for Human Research Protections (OHRP)

Tuesday, March 9, 2010

8:30 am — 8:50 am

Welcome: Opening remarks
Barbara Bierer, M.D.
SACHRP Chair

8:50 am — 9:00 am

Report of Issues/Remarks
Jerry Menikoff, M.D., J.D.,
Director, OHRP

9:00 am — 9:45 am

Summary of Public Comment:
OHRP Draft Guidance on IRB Continuing Review of Research, and IRB Approval of Research with Conditions
Michael Carome, M.D., OHRP

9:45 am — 10:00 am

BREAK

10:00 am — 12:15 pm

Focus on Harmonization: ICH and CTTI
Robert Temple, M.D.
Deputy Center Director for Clinical Science
CDER, FDA

Rob Califf, M.D.
Director, Duke Translational Medicine Institute

Francis Crawley, Ph.D.
Executive Director
Good Clinical Practice Alliance — Europe (GCPA)

12:15 — 1:30 pm

LUNCH

1:30 pm — 3:15 pm

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP
Elizabeth A. Bankert, M.A.
SAS Co-chairs

3:15 pm — 3:30 pm

BREAK

3:30 pm — 4:45 pm

Subpart A Subcommittee Report, cont’d

4:45 pm — 5:00 pm

Public Comment

5:00 pm — 5:15 pm

Wrap-up Discussion and Adjourn

Wednesday, March 10, 2010

8:30 am — 8:45 am

Remarks
Barbara Bierer, M.D.
SACHRP Chair

8:45 am — 10:30 am

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP
Elizabeth A. Bankert, M.A.
SAS Co-chairs

10:30 am — 10:45 am

BREAK

10:45 am — 12:15 pm

Report of Subpart A Subcommittee (SAS), cont'd Informed Consent Working Group discussion

12:15 pm — 1:15 pm

LUNCH

1:15 pm — 2:00 pm

Future SAS Directions,/p>

2:15 pm — 4:00 pm

Introduction of Subcommittee on Harmonization
David Forster, J.D.
Mark Barnes, J.D.

4:00 pm — 4:15 pm

Public Comment

4:15 pm — 4:30 pm

Wrap-up Discussion and Adjourn