October 25, 2016 - October 26, 2016
Webcasts:
Meeting Materials
Agenda
Day 1 - Tuesday, October 25, 2016
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Welcome: Opening Remarks | Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 10:15 a.m. | Subpart A Subcommittee Report: Considerations of Single IRB Review |
Michele Russell-Einhorn, J.D. SAS Co-chair |
10:15 a.m. - 10:30 a.m. | Break | |
10:30 a.m. - 11:30 a.m. | Subpart A Subcommittee Report: Considerations for Single IRB Review |
Michele Russell-Einhorn, J.D. SAS Co-chair |
11:30 a.m. - 12:30 p.m. | Subpart A Subcommitte Report: IRB Written Procedures Draft Guidance |
David Borasky, M.P.H. SAS Co-chair |
12:30 p.m. - 1:30 p.m. | Lunch | |
1:30 p.m. - 3:15 p.m. | Subcommittee on Harmonization Report: "Benchmarking" in Human Subjects Research |
David Forster, J.D. SOH Co-chair |
3:15 p.m. - 4:30 p.m. | Subcommittee on Harmonization Report: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Appendix M |
David Forster, J.D. SOH Co-chair |
4:30 p.m. - 4:45 p.m. | Public Comment | |
4:45 p.m. - 5:00 p.m. | Summary and Adjournment |
Day 2 - Wednesday, October 26, 2016
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Opening Remarks | Jeffrey Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 10:30 a.m. | Subcommittee on Harmonization Report: FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" |
David Forster, J.D. SOH Co-chair |
10:30 a.m. - 10:45 a.m. | Break | |
10:45 a.m. - 12:15 p.m. | Subcommittee on Harmonization Report: Regulatory Considerations in Cluster Randomized Trials |
David Forster, J.D. SOH Co-chair |
12:15 p.m. - 1:00 p.m. | Lunch | |
1:00 p.m. - 2:15 p.m. | Reserved for Discussion of Revised Recommendations | |
2:15 p.m. - 2:30 p.m. | Public Comment | |
2:30 p.m. - 2:45 p.m. | Wrap and Adjournment |