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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 10: Insights into the Collection of Safety Data in Pregnancy

Session Chair(s)

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases

University of Chicago, United States

Susan  Kindig, JD, MD

Susan Kindig, JD, MD

Prior Executive Director, Medical and Drug Safety

United States

This session will focus on enhancing the collection of informative safety data on drug and vaccine use in pregnancy. Points that will be covered include:

  • Ethical and scientific considerations for inclusion of pregnant women in clinical trials
  • Novel approaches to collecting safety data about vaccine use in pregnancy (e.g. COVID vaccines, new RSV vaccine approved in August 2023)
  • Core data elements for pregnancy pharmacovigilance studies using primary source data collection methods

Learning Objective :
  • Explain the ethical issues of both the exclusion and inclusion of pregnant women in clinical trials
  • Describe the challenges and advancements of inclusion of pregnant women in clinical trials to generate primary data
  • Identify the key data required to enable evaluation of the safety of a drug administered in pregnancy
  • Discuss lessons learned regarding prior approaches to safety data collection following vaccination or drug use in pregnancy

Speaker(s)

Anne  Drapkin Lyerly, MD, MA

Ethical Considerations for the Collection of Safety Data in Pregnancy

Anne Drapkin Lyerly, MD, MA

University of North Carolina, United States

Professor, Social Medicine Research; Professor, Obstetrics and Gynecology

Christine  Olson, MD, MPH

CDC COVID-19 Vaccine Pregnancy Registry: Experience and Lessons Learned

Christine Olson, MD, MPH

Centers for Disease Control and Prevention, United States

Medical Officer, Immunization Safety Office/DHQP/NCEZID

Jonathan Luke Richardson, PhD

Medication and Pregnancy - Improving safety data collection, data harmonisation and risk communication using outputs from the IMI ConcePTION project

Jonathan Luke Richardson, PhD

UK Teratology Information Service, United Kingdom

Principal Medical Information Scientist and Data Manager, UK Teratology Informat

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