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Monday, June 20 • 1:15pm - 2:15pm
#108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-511-L04-P ; CME 1.00; RN 1.00

A 2021 FDA guidance discusses a sponsor’s responsibility for IND reporting of anticipated adverse events in studies. This session will discuss how the Aggregate Safety Assessment Plan can assist sponsors in meeting IND reporting responsibilities. Join the DIA Clinical Safety & Pharmacovigilance Community for a follow up round table discussion (session #124 RT) on Monday, June 20, 2:30pm - 3:30pm.

Learning Objectives

Identify the contents of the new FDA Draft guidance on IND safety reporting; Recognize the importance of proactive multidisciplinary aggregate safety assessment planning; Discuss how the Aggregate Safety Assessment Plan (ASAP) supports IND safety reporting decisions; Describe considerations in developing a safety surveillance plan.

Chair

Barbara Hendrickson, MD

Speaker

FDA Update
Jacqueline A. Corrigan-Curay, JD, MD

Industry Update
Greg Ball, PhD

Industry Update
Mengchun Li, MD, MPA



Speakers
avatar for Greg Ball

Greg Ball

Head of Safety Statistics, Global Vaccine Safety, Novavax, Inc., United States
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Principal Deputy Director, Office of the Center Director, CDER, FDA, United States
Jacqueline Corrigan-Curay, J.D., M.D., serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality... Read More →
avatar for Barbara Hendrickson

Barbara Hendrickson

Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc., United States
Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has 18 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in... Read More →
avatar for Mengchun Li

Mengchun Li

Director, Phamacovigilance, Global Alliance For TB Drug Development, United States
Dr. Mengchun Li is the Director of Pharmacovigilance at TB Alliance. In this position, Dr. Li chairs the multidisciplinary safety management team for all compounds and is responsible for clinical safety and pharmacovigilance. Prior to this, Dr. Li worked at Janssen Pharmaceutical... Read More →


Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session |   09: Regulatory, Session