August 22–23, 2019
Location: 6710B Rockledge Drive, Room 1425/1427 (1st Floor), Bethesda, MD 20817
Agenda
Day 1
Thursday, August 22, 2019
| 10:30 a.m. | Open Session Begins |
|---|---|
|
10:30 a.m. |
Welcome and Opening Remarks Diana Bianchi, M.D. |
| 10:35 a.m. | Introduction of Task Force Members |
| 10:45 a.m. | Review and Approval of Minutes from May Meeting Lisa Kaeser, J.D. |
| 10:50 a.m. | Charge and Goals for the Meeting (PDF 245 KB) Diana Bianchi, M.D. |
| 11:10 a.m. | Discussion/Questions |
| 11:15 a.m. | Recent PRGLAC-related Activities FDA’s New Guidance on Working with Pregnant Women in Clinical Trials (PDF 701 KB) Leyla Sahin, M.D. Novartis/European Union Efforts Christina Bucci-Rechtweg, M.D. UK Efforts: Safer Medicines for Pregnant Women and Lactating Women (PDF 119 KB) Lisa Kaeser, J.D. |
| 11:30 a.m. | Discussion/Questions |
| 11:45 a.m. | Public Comment Period |
| 12:45 p.m. | Open Session Adjourns |
| 1:30 p.m. | Working Group Meetings (closed) |
| 5:00 p.m. | End of Day 1 |
Day 2
Friday, August 23, 2019
| 8:00 a.m. | Outline and Goals for Day 2 Diana Bianchi, M.D. |
|---|---|
| 8:15 a.m. | Working Group Presentations Please note: These presentations were used for generating discussion and do not reflect the full content of a final report. |
| 8:15 a.m. | Working Group 1: Research/Training (PDF 108 KB) Andrew Bremer, M.D., Ph.D., and Victoria Pemberton, M.S. |
| 8:45 a.m. | Discussion |
| 9:15 a.m. | Working Group 2: Regulatory (PDF 123 KB) Karin Bok, Ph.D., and Shelli Avenevoli, Ph.D. |
| 9:45 a.m. | Discussion |
| 10:15 a.m. | Break |
| 10:30 a.m. | Working Group 3: Communications (PDF 102 KB) Kaveeta Vasisht, M.D., Pharm.D., and Camille Fabiyi, Ph.D. |
| 11:00 a.m. | Discussion |
| 11:30 a.m. | Working Group 4: Discovery (PDF 106 KB) Elena Gorodetsky, M.D., Ph.D., and Aaron Lopata, M.D. |
| Noon | Discussion |
| 12:30 p.m. | Recap of Meeting and Action Items Diana Bianchi, M.D. |
| 1:00 p.m. | End of Day 2, adjourn meeting |
Return to Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) main page.
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