Thursday, June 25, 2015

Webinar on pregnancy and lactation labeling – what you need to know!

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Wolters Kluwer Health
Clinical Drug Information
RxPerts Academy
Knowledge for the Next Era of Healthcare


The changing label … Understanding the FDA's revisions to pregnancy and lactation labelingmobileHeader
Join Us!
Wednesday, July 8, at 2 p.m. ET

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:

■ 
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
■ 
The challenges of conducting post-marketing studies of medication safety in pregnant women
■ 
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!

PRESENTERS:
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.

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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