NIH Websites Are Changing

Beginning in late July, NIH will start introducing a new website experience designed to make it easier to find health information, research, funding opportunities, and other resources. During the transition, you may notice changes to navigation, page layouts, and where some information is located.

Learn more in our Frequently Asked Questions.

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

Return to Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) main page.