May 25, 2017 - May 26, 2017
Webcasts:
Meeting Materials
Agenda
Day 1 - Thursday, May 25, 2017
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. |
Welcome and Introducton of New Members: |
Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 9:15 a.m. |
Overview of New Final Rule Sections §§__.101(I), __,104(d)(3), and __.110 |
Jerry Menikoff, M.D., J.D. Director, OHRP |
9:15 a.m. - 10:45 a.m. |
Subcommittee on Harmonization Topic: |
David Forster, J.D. SOH Co-chair |
10:45 a.m. - 11:00 a.m. | BREAK | |
11:00 a.m. - 11:30 a.m. |
Subcommittee on Harmonization |
David Forster, J.D. SOH Co-chair |
11:30 a.m. - 12:30 p.m. |
Subpart A Subcommittee Topic: |
Michele Russell-Einhorn, J.D. |
12:30 p.m. - 1:15 p.m. | LUNCH | |
1:15 p.m. - 2:15 p.m. |
Subpart A Subcommittee Topic: |
Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair |
2:15 p.m - 4:15 p.m. | Subpart A Subcommittee Topic: Expedited Review List, §__ .110 |
Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair |
4:15 p.m. - 4:30 p.m. | Public Comment | |
4:30 p.m. - 4:45 p.m. | Summary and Adjournment |
Day 2 - Friday, May 26, 2017
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Opening Remarks | Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 9:00 a.m. | Overview of New Final Rule Section, §__ .116 (d) | Jerry Menikoff, M.D., J.D. Director, OHRP |
9:00 a.m. - 10:30 a.m. | Subcommittee on Harmonization Topic: Broad Consent, §__ .116 (d) |
Mark Barnes, J.D. SOH Co-chair |
10:30 a.m. - 10:45 a.m. | BREAK | |
10:45 a.m. - 11:30 a.m. | Subcommittee on Harmonization Topic: Broad Consent, §__ .116 (d) |
Mark Barnes, J.D. SOH Co-chair |
11:30 a.m. - 12:15 p.m. | Subcommittee on Harmonization Topic: Report of Incidental Findings |
David Forster, J.D. SOH Co-chair |
12:15 p.m. - 1:00 p.m. | LUNCH | |
1:00 p.m. - 2:00 p.m. | Subcommittee on Harmonization Topic: FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" |
David Forster, J.D. SOH Co-chair |
2:00 p.m. - 3:30 p.m. | Reserved for Discussion of Revised Recommendations | |
3:30 p.m. - 3:45 p.m. | Public Comment | |
3:35 p.m. - 4:00 p.m. | Wrap and Adjournment |