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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 11: Pregnancy and Lactation: How Are we Going to Get Useful Data?

Session Chair(s)

Susan  Kindig, JD, MD

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


Amalia  Alexe

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

Aaron  Pawlyk, PhD

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

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