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Monday, June 19 • 11:00am - 12:15pm
#118: Counting on Safety

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

The regulatory landscape for safety monitoring is evolving, particularly in emerging regulation/guidance from the US FDA and EMA. This maturing regulatory landscape calls for a systematic and proactive process, multi-disciplinary collaboration, quantitative framework/methods/tools, built on a solid safety data architecture. This session will feature presentations on global safety monitoring regulations and the relevant clinical and statistical considerations. The FDA IND safety reporting final rule will be reviewed (FDA speaker invited). The design consideration to align with the recent guidance of the FDA IND safety reporting final rule will be shared by an industry representative.

Learning Objectives

Discuss the latest regulatory landscape for safety monitoring.

Chair

William Wang, PhD

Speaker

IND Safety Reporting
Stephanie Shapley, MBA

Safety Assessment Committees: More Than One Way to Navigate the Pharmacovigilance Seas
Barbara A. Hendrickson, DrMed, MD

Systems Theoretic Process Analysis : A New Way to Strengthen Pharmacovigilance Processes - A Case Study
Alan M. Hochberg


Moderators
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... Read More →

Speakers
BH

Barbara Hendrickson

Senior Medical Director, AbbVie, Inc.
Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety and Co-lead of the Safety Statistics Excellence program at AbbVie. She is a physician with 13 years of pharmaceutical industry experience and 15 years in academic research with sub... Read More →
avatar for Alan Hochberg

Alan Hochberg

Scientific Enablement Leader, F. Hoffmann-La Roche Ltd.
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engin... Read More →
SS

Stephanie Shapley

Associate Director for Regulatory Affairs, OMPI, OMP, CDER, FDA
Stephanie Shapley is the Associate Director for Regulatory Affairs in the Office of Medical Policy Initiatives, within the Office of Medical Policy in FDA's Center for Drug Evaluation and Research.
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... Read More →

Monday June 19, 2017 11:00am - 12:15pm
S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Forum