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Clinical Drug Information
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RxPerts Academy
Knowledge for the Next Era of Healthcare
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Join Us!
Wednesday, July 8, at 2 p.m. ET
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On June 30, 2015, a final rule issued by the FDA goes
into effect and changes the way labeling information is presented on
prescription medications used during pregnancy and breastfeeding. The
rule will do away with the familiar letter labeling categories – A, B, C,
D, and X - in favor of more detailed information on clinical
considerations and risks to pregnant women and new mothers, as well as
supporting data, categorized in three subsections.
Are you prepared to begin using these new labels?
Wolters Kluwer Clinical Drug Information wants to help
you navigate these labeling changes. Clinicians and researchers will want
reserve an hour to review the FDA's new requirements with three
stakeholders in the Vaccines and Medications in Pregnancy Surveillance
System (VAMPSS) – Drs. Michael Schatz, Christina Chambers, and Allen A.
Mitchell – in the webinar "The New Pregnancy and Lactation Labeling
Rule: Implications for Clinical Practice."
Mark your calendars for Wednesday, July 8, at 2 p.m. ET to
explore:
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The new Pregnancy and Lactation Labeling Rule,
including new formatting and content requirements and standards for how
information is presented in the pregnancy and lactation sections of
labeling for prescription drugs and biological products
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The challenges of conducting post-marketing studies
of medication safety in pregnant women
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The design and application of The Vaccines and
Medications in Pregnancy Surveillance System (VAMPSS) as an approach
for conducting post-market surveillance and studies of medical product
safety for pregnant and lactating women
Strengthen medication decision making today with
help from the Wolters Kluwer Clinical Drug Information RxPerts Academy
webinar series!
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Michael Schatz, MD, MS, has been a staff allergist at
Kaiser-Permanente Medical Center in San Diego since 1977, where he
served as Chief of the Allergy Department from 2000-2011. He is also
a clinical professor in the Department of Medicine at the University
of California, San Diego School of Medicine. Dr. Schatz serves as the
American Academy of Allergy, Asthma, and Immunology principal
investigator for the Vaccines and Medications in Pregnancy
Surveillance System (VAMPSS). He received his MD from Northwestern
University Medical School, Chicago, Illinois, and his Master of
Science in Epidemiology from the Harvard School of Public Health.
Christina Chambers, PhD, MPH, is a perinatal epidemiologist and
teratologist whose research is focused on environmental causes of birth
defects and other adverse pregnancy and child health outcomes. She is
a professor in the Department of Pediatrics and Family Medicine and
Public Health, director of Clinical Research for the Department of
Pediatrics, and she directs the Center for Better Beginnings at the
University of California San Diego (UCSD). She also holds an
appointment in the Skaggs School of Pharmacy and Pharmaceutical
Sciences at UCSD. Dr. Chambers also leads the cohort arm of the
Vaccines and Medications in Pregnancy Surveillance System (VAMPSS).
She received her PhD in public health and epidemiology from UCSD.
Allen A. Mitchell, MD, is professor of epidemiology and pediatrics
at the Boston University Schools of Public Health and Medicine and
director of the Slone Epidemiology Center at Boston University. In
1976, he was the founding principal investigator of the Slone Birth
Defects Study, an ongoing multi-center case-control surveillance
study of medication risks/safety in pregnancy. Dr. Mitchell also
serves as a principal investigator for the Massachusetts Center in
the CDC's National Birth Defects Prevention Study (NBDPS) and its
successor, BD-STEPS, and works with the American Academy of Allergy,
Asthma, and Immunology Vaccines and Medication in Pregnancy Safety
Surveillance (VAMPSS) program.
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P.S.: Schedule conflict? Sign Up anyway and receive a copy of the slides and access to
the on-demand presentation.
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"The New Pregnancy and Lactation Labeling Rule:
Implications for Clinical Practice" is sponsored by Wolters Kluwer
Clinical Drug Information, featuring Medi-Span®, Lexicomp®, and Facts &
Comparisons® applications.
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If you would like to contact Wolters
Kluwer Clinical Drug Information with questions, concerns or for general
information, please visit our Contact Us page.
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trademarks featured or referred to within this email are the property of
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endorsement or affiliation. Visit our Trademarks & Logos page for more information.
© 2015 Wolters Kluwer Clinical Drug
Information, Inc. and its affiliates and/or licensors. All rights reserved.
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