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DIA 2021 Global Annual Meeting

The Spirit of the IND Safety Reporting Final Rule

Session Chair(s)

Greg Ball, PhD

Greg Ball, PhD

  • Senior Principal Biostatistician
  • Merck & Co., Inc., United States
This session will emphasize the importance of having a thoughtful process; a system in place to look for clinically important imbalances, applying the best clinical and quantitative judgment, while maintaining trial integrity.
Learning Objective : Discuss how to leverage the scientific expertise and medical judgment of sponsor safety teams with 1) a multidisciplinary approach, 2) quantitative frameworks for measuring evidence of association, 3) assessments customized for the specific product, and 4) decisions that incorporate medical judgment.

Speaker(s)

Amy Freedman, MD, MPH

Anticipated Events Safety Monitoring Plan (ASMP)

Amy Freedman, MD, MPH

  • Therapeutic Area Safety Head, Cardiovascular Metabolism
  • Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Barbara Hendrickson, MD

Safety Assessment Committee (SAC) Pilot

Barbara Hendrickson, MD

  • Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety
  • AbbVie, Inc., United States
Robert J. Temple, MD

Discussant

Robert J. Temple, MD

  • Deputy Center Director for Clinical Science, Office of the Center Director, CDER
  • FDA, United States