Pregnancy and Lactation: How are we Going to Get Useful Data?

Wednesday, December 6, 2023 |12:00 – 1:15PM ET

In this webinar...

Join us for a replay of one of the highest rated session from the 2023 Global Pharmacovigilance and Risk Management Strategies Conference. This webinar will feature our current Program Chair, Jim Buchanan, PharmD, President Covilance LLC, and Tamei Elliott, M.S., Associate Director, Scientific Programs (Americas) who will share with all of you the offerings at the 2024 Global Pharmacovigilance and Risk Management Strategies Conference. We will then jump right into the content:

Pregnancy and Lactation: How Are we Going to Get Useful Data?

This session will provide the audience with a review of the latest information and initiatives in understanding the safety and efficacy of drug use in pregnancy and lactation. Attendees will hear 2023 updates on the ConcePTION project and a description of the various workstreams that are ongoing. Additionally, you’ll gain insights on what the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) group developed and discuss upcoming work related to pregnancy and lactation. Lastly, leave the session by identifying innovative ideas for gathering data that were stimulated by the COVID-19 pandemic and recognize how to interpret pharmacovigilance guidance and regulations.

Learning Objectives:

At the conclusion of this session, participants should be able to:
  • Describe the ConcePTION workstreams and how they will aid in pregnancy and lactation data generation
  • Explain the recommendations by the PRGLAC task force and how they are being implemented
  • Recognize how to interpret pharmacovigilance guidance and regulations and how it can aid pharmaceutical companies

Moderators:

Jim Buchanan, PharmD, President Covilance LLC
Tamei Elliott, M.S., Associate Director, Scientific Programs (Americas)

Session Chair:

Susan Kindig, JD, MD, Executive Director, Medical & Drug Safety, Halozyme

Speakers:

Maternal and Fetal Health Initiatives: IMI ConcePTION and TransCelerate Pregnancy and Breastfeeding Group
Amalia Alexe, Policy & Liaison Lead, QPPV PRRC Office, Advanced Accelerator Applications, A Novartis Company, Switzerland

An Update on the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
Aaron Pawlyk, Chief, OPPTB Research Programs, NIH