October 25-26, 2016 - SACHRP Meeting

October 25, 2016 - October 26, 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11:30 a.m. - 12:30 p.m.	Subpart A Subcommitte Report: IRB Written Procedures Draft Guidance	David Borasky, M.P.H. SAS Co-chair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

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8:45 a.m. - 10:30 a.m.	Subcommittee on Harmonization Report: FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices"	David Forster, J.D. SOH Co-chair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