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Wednesday, June 19 • 3:15pm - 4:15pm
#359: A Safety Surveillance Plan for Serious Anticipated Events

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

Learning Objectives

Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

Chair

Greg Ball, PhD

Speaker

Panelist
Susan Talbot

Panelist
Ranjeeta Sinvhal, MD

Panelist
Susan Kindig, JD, MD


Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
avatar for Susan Kindig

Susan Kindig

Prior Executive Director, Medical and Drug Safety, United States
Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience... Read More →
avatar for Ranjeeta Sinvhal

Ranjeeta Sinvhal

Executive Medical Director, Medical Safety, AbbVie, United States
Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety... Read More →
ST

Susan Talbot

Director Biostatistics, Amgen, United States

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum