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Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women
Session Chair(s)
Leyla Sahin, MD
Deputy Director for Safety, DPMH, OND, CDER
FDA, United States
This session will explore the challenges of conducting postmarketing studies in pregnant women. Key messages from the 2014 FDA public meeting will be presented and discussed. Industry will discuss implementation of pregnancy registries as well as methodological considerations for categorization of subjects as retrospective vs. prospective and birth outcomes, and coding of birth defects. Regulatory experts from the United States and Europe and industry will participate in a panel discussion about the current thinking and experiences in the approaches to postmarketing data collection in pregnant women.
Learning Objective : Discuss current challenges in developing pregnancy registries and other studies in the postmarketing setting; Identify best practices for conducting pregnancy registries; Describe different strategies for collection of pregnancy safety data by different organizations including how to improve collaboration.
Speaker(s)
Product Exposure Pregnancy Registries: Experience with and Practical Advice on Data Summarization Conventions
Catherine Sigler, DVM, PhD, MPH
UBC, An Express Scripts Company, United States
Executive Director, Safety, Epidemiology, Registries, & Risk Management (SERRM)
Key Messages From the FDA 2014 Meeting
Melissa S. Tassinari, PhD
Consultant , United States
Former Senior Clinical Advisor, DPMH, OND, CDER, FDA
EMA Point of View
Kevin Blake, MD, PhD
European Medicines Agency, Netherlands
Clinical Epidemiologist