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PRODID:-//Coalition to Advance Maternal Therapeutics - ECPv6.15.20//NONSGML v1.0//EN
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X-WR-CALNAME:Coalition to Advance Maternal Therapeutics
X-ORIGINAL-URL:https://safemeds4moms.org
X-WR-CALDESC:Events for Coalition to Advance Maternal Therapeutics
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TZID:UTC
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DTSTART:20210101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20230214T130000
DTEND;TZID=UTC:20230214T140000
DTSTAMP:20260429T123624
CREATED:20230214T214710Z
LAST-MODIFIED:20230228T194715Z
UID:182-1676379600-1676383200@safemeds4moms.org
SUMMARY:PRGLAC Then and Now: Where We Are and Where We’re Going
DESCRIPTION:The 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of the U.S. Department of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The Task Force’s work culminated in a set of recommendations based on information gleaned during four open meetings and a public comment period. The central theme of those recommendations was “the need to alter cultural assumptions that have significantly limited scientific knowledge of therapeutic product safety\, effectiveness\, and dosing for pregnant and lactating women.” \nDuring this congressional briefing and national webinar\, designed specifically for—but not limited to—members of the 118th Congress\, panelists reviewed the state of PRGLAC\, the PRGLAC recommendations and their implementation status\, the current legislative and regulatory landscape\, and reviewed actions that can be taken at the federal level to increase representation of these populations in clinical trials. \nPanelists\n\nDiana Bianchi\, MD\, Director\, the Eunice Kennedy Shriver National Institute of Child Health and Human Development\, National Institutes of Health\nJennita Reefhuis\, PhD\, Branch Chief\, Birth Defects Monitoring and Research Branch\, Centers for Disease Control and Prevention Division of Birth Defects and Infant Disorders\nKaveeta Vasisht\, MD\, PharmD\, Associate Commissioner for Women’s Health\, U.S. Food and Drug Administration\n\nThis event is part of a series about the inclusion of pregnant and lactating peoples in research hosted by the Coalition. The full series includes: \n\nAddressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6\, 2022)\nPregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26\, 2023)\nPRGLAC Then and Now: Where We Are and Where We’re Going (February 14\, 2023)
URL:https://safemeds4moms.org/event/prglac-then-and-now-where-we-are-and-where-were-going/
CATEGORIES:Congressional Briefing
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BEGIN:VEVENT
DTSTART;TZID=UTC:20230126T110000
DTEND;TZID=UTC:20230126T120000
DTSTAMP:20260429T123624
CREATED:20230214T214134Z
LAST-MODIFIED:20230214T214134Z
UID:181-1674730800-1674734400@safemeds4moms.org
SUMMARY:Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind
DESCRIPTION:Pregnant and lactating populations are routinely left out of clinical trials\, leaving these populations and their health care providers with a dearth of information about which vaccines or diagnostic devices may be safe and effective for both mother and baby. \nThe lack of information about the safety and efficacy of the COVID-19 vaccine for pregnant and lactating populations—due in part to poorly justified concerns about the safety of medications and vaccines during pregnancy—led to a significant delay in getting pregnant people included in clinical trials. As a result\, these families missed an important health prevention opportunity\, and may have suffered as a result. COVID-19\, though one example\, is not the only example of how excluding these populations has led to unanswered questions that could improve health outcomes for pregnant and lactating populations and their families. \nDuring this congressional briefing and national webinar\, panelists explored certain areas of research where the exclusion of these groups has resulted in an inability to support them\, how federal research investments could improve outcomes\, and where there is opportunity—both at the legislative and regulatory level—moving forward. \nPanelists\n\nChristina Chambers\, PhD\, MPH (Moderator)\, Professor\, Pediatrics\, School of Medicine at University of California San Diego; Chief\, Division of Environmental Science and Health and Co-Director\, Center for Better Beginnings\nAnne Drapkin Lyerly\, MD\, MA\, Professor\, Social Medicine\, Research Professor\, OBGYN\, University of North Carolina\, Chapel Hill\nKara Polen\, MPH\, Associate Director for Communications\, Division of Birth Defects and Infant Disorders\, Centers for Disease Control and Prevention\n\nThis event is part of a series about the inclusion of pregnant and lactating peoples in research hosted by the Coalition. The full series includes: \n\nAddressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6\, 2022)\nPregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26\, 2023)\nPRGLAC Then and Now: Where We Are and Where We’re Going (February 14\, 2023)
URL:https://safemeds4moms.org/event/pregnant-and-lactating-populations-in-research-how-leaving-these-populations-out-leaves-them-behind/
CATEGORIES:Congressional Briefing
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20221206T140000
DTEND;TZID=UTC:20221206T150000
DTSTAMP:20260429T123624
CREATED:20230214T213525Z
LAST-MODIFIED:20230214T213616Z
UID:180-1670335200-1670338800@safemeds4moms.org
SUMMARY:Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research
DESCRIPTION:Pregnant and lactating women have historically been excluded from clinical trials. Federal policies from the 1970s that excluded “women of childbearing age” from research led research to use male participants\, limiting our knowledge base. Although a 1994 report from the Institute of Medicine recommended that pregnant women be presumed to be eligible to participate in clinical studies and that lactating women not be excluded from clinical studies\, concerns remain about including pregnant and lactating populations in research. \nDuring this virtual congressional briefing and national webinar\, panelists reviewed ethical considerations surrounding inclusion of pregnant and lactating women in research\, how to ensure the appropriate inclusion of these populations\, and the current state of this type of inclusion in research\, both within the federal government and the corporate sector. \nPanelists\n\nDrew Hatter (Moderator)\, Federal Affairs Strategist\, American College of Obstetricians and Gynecologists (ACOG)\nChristina Bucci-Rechtweg\, MD\, Head\, Pediatric & Maternal Health Policy\, Global Drug Development and Regulatory Affairs\, Novartis Pharmaceutical Corporation\nAaron Pawlyk\, PhD\, Chief\, Obstetric and Pediatric Pharmacology and Therapeutics Branch\, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)\nLeyla Sahin\, MD\, Deputy Director for Safety\, Division of Pediatrics and Maternal Health\, Office of New Drugs\, Center for Drug Evaluation and Research\, U.S. Food and Drug Administration (FDA)\nCatherine Spong\, MD\, Professor and Chair\, Department of Obstetrics and Gynecology; Chief\, Division of Maternal Fetal Medicine; Paul C. MacDonald Distinguished Chair in Obstetrics and Gynecology\, University of Texas Southwestern Medical Center\n\nThis event is part of a series about the inclusion of pregnant and lactating peoples in research hosted by the Coalition. The full series includes: \n\nAddressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6\, 2022)\nPregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26\, 2023)\nPRGLAC Then and Now: Where We Are and Where We’re Going (February 14\, 2023)
URL:https://safemeds4moms.org/event/addressing-concerns-and-considerations-surrounding-the-inclusion-of-pregnant-and-lactating-populations-in-research/
CATEGORIES:Congressional Briefing
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