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Monday, June 24 • 2:15pm - 3:15pm
Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity

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Component Type: Session
Level: Basic

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc

Speaker

Academia Perspective
Darren Toh, DrSc, FISPE

Analytics Perspective
Jeremy Rassen, DrSc

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim
JR

Jeremy Rassen

Co-Founder, President and Chief Science Officer, Aetion
avatar for Darren Toh

Darren Toh

Associate Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
Darren Toh, ScD is an Associate Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. He is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
  • Tags Session