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Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)

August 22–23, 2019

Location: 6710B Rockledge Drive, Room 1425/1427 (1st Floor), Bethesda, MD 20817

Agenda

August 22, 2019
August 23, 2019

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

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