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NICHD Archive Note: Information on this page was accurate at the time of publication. This page is no longer being updated. |
May 14–15, 2018
Location: 6710B Rockledge Drive, Room 1425/1427 (1st Floor), Bethesda, MD 20817
Agenda
Day 1
Monday, May 14, 2018
| 8:30 a.m. | Welcome and Opening Remarks Catherine Spong, M.D. |
|---|---|
| 8:35 a.m. | Review and Approval of Minutes from February’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 1–3 (PDF 611 KB) Catherine Spong, M.D. |
| 9:15 a.m. | Open Discussion |
| 9:45 a.m. |
Break |
| 10:00 a.m. | Public Comment Period |
| 10:45 a.m. | Summary of Request for Information (PDF 333 KB) Lisa Kaeser, J.D.
|
| 11:15 a.m. | FDA Presentation on Risk Communication Advisory Committee Meeting on the Pregnancy and Lactation Labeling Rule and New Guidance for Industry on Pregnant Women (PDF 306 KB) Lynne Yao, M.D. |
| 11:35 a.m. | Review of Historical Recommendations in Pregnancy and Lactation (PDF 384 KB) Elizabeth Wehr, J.D. |
| 11:50 a.m. | Open Discussion |
| 12:15 p.m. |
LUNCH |
| 1:15 p.m. | Incentives and Liability Discussion (PDF 47 KB) Panelists:Christina Bucci-Rechtweg, M.D.; Kristi Lengyel, M.B.A.; Jeanne Sheffield, M.D.; Robert Ternik, Ph.D.; Kathleen Miller, Ph.D.; and Lynne Yao, M.D. Moderator: Karin Bok, Ph.D., M.S. |
| 2:00 p.m. | Recommendations to Improve the Development of Safe and Effective Therapies for Pregnant Women and Lactating Women, Including Topics Covered from Meetings 1–3* |
| 2:00 p.m. | Discussion on Strategy and Structure for Recommendations (PDF 92 KB) Catherine Spong, M.D. |
| 2:15 p.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 Catherine Spong, M.D. Moderator: Shelli Avenevoli, Ph.D. |
| 2:45 p.m. | Ethical Issues Surrounding the Inclusion of Pregnant Women and Lactating Women in Clinical Research Catherine Spong, M.D. Moderator: Shelli Avenevoli, Ph.D. |
| 3:15 p.m. | Open Discussion |
| 3:45 p.m. |
Break |
| 4:00 p.m. | Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women Catherine Spong, M.D. Moderator: Jeanna Piper, M.D. |
| 4:20 p.m. | Federal Activities: State of Research, Coordination and Collaboration on Research, Dissemination of Research Findings, and Existing Federal Efforts Catherine Spong, M.D. Moderator: Jeanna Piper, M.D. |
| 4:45 p.m. | Open Discussion |
| 5:00 p.m. | Recap of Meeting, Action Items, and Charge to the Group Catherine Spong, M.D. |
| 5:00 p.m. |
End of day 1 |
*Time will be adjusted for these topics, and there is open discussion on day 2 from 8:00 a.m. to 11:45 a.m. that is available if the scheduled time is not sufficient.
Day 2
Tuesday, May 15, 2018
| 8:00 a.m. | Recap of Day 1 and Outline and Goals for Day 2 Catherine Spong, M.D. |
|---|---|
| 8:15 a.m. | Open Discussion: Recommendations to Improve the Development of Safe and Effective Therapies for Pregnant Women and Lactating Women Moderator: Andrew Bremer, M.D., Ph.D. |
| 10:00 a.m. |
BREAK |
| 10:15 a.m. | Open Discussion, continued |
| 11:45 p.m. |
Lunch |
| 12:45 p.m. | Review of Recommendations with Voting Catherine Spong, M.D.
|
| 2:00 p.m. | Recap of Meeting, Action Items, and Charge to the Group (PDF 262 KB) Catherine Spong, M.D. |
| 2:30 p.m. |
End of day 2, adjourn meeting |
Return to Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) main page.
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