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

August 21-22, 2017

Agenda

August 21, 2017

8:30 a.m. Welcome and Opening Remarks
Lawrence Tabak, DDS, PhD
8:40 a.m. Introductions
9:00 a.m. Background, Timeline, Goals, and Report (PDF - 1.2 MB)
Catherine Spong, MD
9:30 a.m. Scope of the Task Force
9:30 a.m. Scope from Development and Legislation (PDF - 680 KB)
Kathryn Schubert, MPP
9:45 a.m. Discussion
  • Population: pregnant women, lactating women
  • Therapies: drugs (prescription, over-the-counter), vaccines, alternative therapies, non-drug interventions
  • Feasibility
10:45 a.m. BREAK
11:00 a.m. State of Research on Pregnancy and Lactation (PDF - 1.85 MB)
Anne Zajicek, MD, PharmD
 11:45 a.m. Q&A
12:00 p.m. LUNCH
12:45 p.m. Identification of Federal Activities
 
12:45 p.m.
Overview of Federal Activities (PDF - 405 KB)
Catherine Spong, MD
 
12:50 p.m.
National Institutes of Health (PDF - 360 KB)
Diana Bianchi, MD
 
1:00 p.m.
Centers for Disease Control and Prevention (PDF - 2.5 MB)
Athena P. Kourtis, MD, PhD
 
1:10 p.m.
Food and Drug Administration (PDF - 1.9 MB)
Marjorie R. Jenkins, MD, MEdHP, FACP
 
1:20 p.m.
Q&A and Discussion
 
1:30 p.m.
HHS Office of the Assistant Secretary for Health (PDF - 238 KB)
Sayeedha Uddin, MD, MPH
 
1:40 p.m.
Agency for Healthcare Research and Quality (PDF - 121 KB)
Camille Fabiyi, PhD, MPH
 
1:50 p.m.
Health Resources and Services Administration (PDF - 131 KB)
Lee Andrew Wilson, MS
 
2:00 p.m.
Department of Defense (PDF - 222 KB)
Terry Adirim, MD, MPH
2:10 p.m. Q&A and Open Public Discussion
2:00-2:30

Panel discussion of overarching questions
Panel participants:

  • Vanessa Van der Linden, M.D.
  • Carmen Zorrilla, M.D.
  • William Britt, M.D.
  • Sonja Rasmussen, M.D.
  • Phil Heine, M.D.
2:15 p.m. BREAK – Eclipse viewing time Bring your own protective eyewear
3:00 p.m. Identification of Federal Activities (Continued)
 
3:00 p.m.
National Vaccine Program (PDF - 711 KB)
Karin Bok, PhD, MS
 
3:10 p.m.
Veterans Affairs (PDF - 853 KB)
Laurie Zephyrin, MD, MPH, MBA
 
3:20 p.m.
Q&A and Open Public Discussion
 
3:30 p.m.
Other Federal Efforts (PDF - 223 KB)
Sarah Glavin, PhD
3:40 p.m. Open Public Discussion and Identification of Additional Activities
4:35 p.m. Recap of Day 1 and Charge for Day 2
Catherine Spong, MD
5:00 p.m. END OF DAY 1

 

 

August 22, 2017

8:30 a.m. Recap of Day 1 and Outline and Goals for Day 2
Catherine Spong, MD
8:45 a.m. Panel Discussion: Recommendations for coordination of and collaboration on research related to pregnant women and lactating women
8:45 a.m. Brief overview presentations outlining current and opportunities for coordination/collaboration
8:45 a.m. NIH Perspective (PDF - 600 KB)
Diana Bianchi, MD
8:55 a.m. FDA Perspective (PDF - 901 KB)
Marjorie R. Jenkins, MD, MEdHP, FACP
9:05 a.m. Industry Perspective (PDF - 236 KB)
Christina Bucci-Rechtweg, MD
9:15 a.m. Panel Discussion

Panelists: Diana Bianchi, MD; Christina Bucci-Rechtweg, MD; Marjorie R. Jenkins, MD, MEdHP, FACP; Susan Givens, RN; Jeanne Sheffield, MD; Sayeedha Uddin, MD, MPH; Kristi Lengyel
  • Current coordination and collaboration
  • Opportunities for coordination and collaboration
  • Challenges to coordination and collaboration
9:45 a.m. Q&A and Open Public Discussion
10:30 a.m. BREAK
10:45 a.m. Public Comment Period
11:30 a.m. LUNCH
12:30 p.m. Panel presentation and discussion: Dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public
12:30 p.m. Overview Presentations Outlining Current Efforts on Dissemination of Research and Information
12:30 p.m. Professional Society Perspective (PDF - 387 KB)
Michael Greene, MD
12:40 p.m. Patient Perspective (PDF - 120 KB)
Jamie Zahlaway Belsito
12:50 p.m. CDC Perspective (PDF - 1.8 MB)
Athena P. Kourtis, MD, PhD
1:00 p.m. Panel Discussion

Panelists: Michael Greene, MD; Jamie Zahlaway Belsito; Athena P. Kourtis, MD, PhD; Siobhan Dolan, MD; Tekoa King, MPH; Lee Andrew Wilson, MS
  • Current Dissemination of Research and Information
  • Opportunities for Dissemination of Research and Information
  • Challenges to Dissemination of Research and Information
1:30 p.m. Q&A, and Discussion
2:15 p.m. Open Public Discussion
2:45 p.m. BREAK
3:00 p.m. Outline of Overarching Recommendations from Panels
Panelists: Bridgette Jones, MD; Diane Spatz, PhD; Robert Ternik, PhD; Linda Lipson, MA
4:15 p.m. Recap of Meeting, Action Items, and Charge to Group (PDF - 93 KB)
Catherine Spong, MD
4:30 p.m. END OF DAY 2, ADJOURN MEETING

 

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