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Session 11: Pregnancy and Lactation: How Are we Going to Get Useful Data?
Session Chair(s)
Susan Kindig, JD, MD
Prior Executive Director, Medical and Drug Safety
United States
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. We will discuss update on the ConcePTION project and a description of the various workstreams that are ongoing. We will also present what the PRGLAC group developed and discuss upcoming work related to pregnancy and lactation. Additionally, the work and solutions that TransCelerate has been working on will be discussed and reviewed. Lastly, we will identify innovative ideas for gathering data that were stimulated by the COVID-19 pandemic.
Learning Objective : 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 the Interpretation of Pharmacovigilance Guidance & Regulations Solutions from TransCelerate and how it can aid pharmaceutical companies
Speaker(s)
Maternal and Fetal Health Initiatives: IMI ConcePTION and TransCelerate Pregnancy and Breastfeeding Group
Amalia Alexe
Advanced Accelerator Applications, A Novartis Company, Switzerland
Policy and Liaison Lead, QPPV Office
An Update on the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
Aaron Pawlyk, PhD
NIH/NICHD, United States
Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch