Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.

Updates regarding government operating status and resumption of normal operations can be found at OPM.gov.

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

February 26–27, 2018

Agenda

February 26, 2018

8:30 a.m. Welcome and Opening Remarks
Catherine Spong, M.D.
8:35 a.m. Review and Approval of Minutes from November's Meeting
Catherine Spong, M.D.
8:40 a.m. Introduction of Task Force members
8:45 a.m. Summary and Discussion of Work Products from Meetings 1 and 2
8:45 a.m. Review of Work Products and Recommendations from Meetings 1 and 2
Catherine Spong, M.D.
9:15 a.m. Discussion
9:45 a.m. BREAK
10:00 a.m. Public Comment Period
10:45- a.m. Panel: Lessons Learned from Pediatric Research

Brief Overview of Presentations
10:45
Community involvement/groundswell
Mark Del Monte, J.D.
 
10:55
Best Pharmaceuticals for Children Act (BPCA) overview (PDF 182 KB)
Anne Zajicek, M.D., Pharm.D., FAAP
 
11:05
NIH and BPCA (PDF 263 KB)
Perdita Taylor-Zapata, M.D.
 
11:15
FDA and BPCA (PDF 261 KB)
Lynne Yao, M.D., FAAP
 
11:25
Industry perspective (PDF 1.9 MB)
Samuel Maldonado, M.D., M.P.H., FAAP
 
11:35 a.m. Discussion
Moderator: Andrew Bremer, M.D., Ph.D.
12:15 p.m. LUNCH
1:15 p.m. Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women
1:15 p.m. Communication Strategy Case Example: NICHD Safe to Sleep® Campaign (PDF 1 MB)
Lorena Kaplan, M.P.H., CHES
1:50 p.m. Panel: Effective Communication Strategies with Health Care Providers on Information Relevant to Pregnant Women and Lactating Women

Brief Overview of Presentations
1:50
Federal perspective
John Whyte, M.D., M.P.H.
 
2:00
Professional society perspective (PDF 510 KB)
Kerri Wade, M.P.A.
 
2:10
Industry perspective
Susan Kindig, M.D., J.D.
 
2:20
Health care provider perspective (PDF 225 KB)
Susan Givens, RNC-OB, M.P.H., LCCE
 
2:30 p.m. Discussion
Moderator: Jeanna Piper, M.D.
Additional panelists: Jeanne Sheffield, M.D., and Victoria Pemberton, RNC, M.S., CCRC
3:15 p.m. BREAK
3:30 p.m. Panel: Effective Communication Strategies with the Public on Information Relevant to Pregnant Women and Lactating Women

Brief Overview of Presentations
3:30
Federal perspective (PDF 4 MB)
Jackie Rosenthal, M.P.A.
 
3:40
Professional society perspective (PDF 1 MB)
Bridgette Jones, M.D.
 
3:50
Professional organization perspective (PDF 1.3 MB)
Diane Spatz, Ph.D.
 
4:00
Industry perspective (PDF 338 KB)
Kristi Lengyel, M.B.A.
 
4:10
Patient perspectives (PDF 165 KB)
Susan Benjamin Feingold, Psy.D.
 
4:20 p.m. Discussion
Moderator: Karin Bok, M.S., Ph.D.
Additional panelists:Melissa Gorman, M.S.N., RN-BC, CCRN-K, and Lois Tschetter, Ed.D., RN, IBCLC, CNE
4:50 p.m. Recap of Meeting, Action Items, and Charge to Group
Catherine Spong, M.D.
5:00 p.m. END OF DAY 1

 

February 27, 2018

8:00 a.m. Recap of Day 1 and Outline and Goals for Day 2
Catherine Spong, M.D.
8:15 a.m. A Plan to Identify and Address Gaps in Knowledge and Research Regarding Safe and Effective Therapies for Pregnant Women and Lactating Women, Including the Development of Such Therapies
8:15 a.m. Discussion: Options for a Plan or Plans
Moderator: Shelli Avenevoli, Ph.D.
10:00 a.m. BREAK
10:15 a.m. Discussion Continues
Moderator: Shelli Avenevoli, Ph.D.
11:45 p.m. LUNCH
12:45 p.m. Discussion of Key Points and Review of Recommendations
12:45 p.m. Discussion of Key Points for Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women
Catherine Spong, M.D.
1:30 p.m. Discussion of Key Points for a Plan to Identify and Address Gaps in Knowledge and Research Regarding Safe and Effective Therapies for Pregnant Women and Lactating Women, Including the Development of Such Therapies
Catherine Spong, M.D.
2:15 p.m. Review of Recommendations from Meetings 1, 2, and 3
Catherine Spong, M.D.
2:45 p.m. Recap of Meeting, Action Items, and Charge to Group (PDF 168 KB)
Catherine Spong, M.D.
3:00 p.m. END OF DAY 2, ADJOURN MEETING

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

top of page BACK TO TOP