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


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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