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Monday, June 24 • 2:15pm - 3:15pm
#135: 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
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

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, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim
Kim Brodovicz is Executive Director, Late Stage Cardiometabolism Team Lead in Global Epidemiology and Real World Evidence at Boehringer Ingelheim. Kim has supported drugs and vaccines from early development to post-approval in a variety of therapeutic areas and has conducted numerous... Read More →
NC

Noelle Cocoros

Research Scientist, Department of Population Medicine, Harvard Medical School
avatar for Jeremy Rassen

Jeremy Rassen

Co-Founder, President and Chief Science Officer, Aetion
Jeremy A. Rassen, MS, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 6D 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
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session