DIA 2021 Global Annual Meeting

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Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process

Session Chair(s)

Jamie Wilkins, PHARMD

Head, Risk Management Center of Excellence, Pfizer Inc, United States

This session will review FDA’s Newly Identified Safety Signal (NISS) process, and also assess its impact to industry. The impact assessment considers approaches to integrate signal detection methodology and internal processes to address a NISS.

Learning Objective : Describe the FDA Newly Identified Safety Signal (NISS) evaluation process; Explain the analysis of safety data sources, intake and analysis relevant to a NISS undertaken by a large pharmaceutical company; Identify key information within the session which could be used to formulate a plan to address a NISS received by the participant’s organization.

Speaker(s)

Jason Bunting, PHARMD

Science Policy Analyst, Office of the Center Director, CDER, FDA, United States

FDA Update

Bertha V Ferrer, MSC, RPH

Senior Director, Head of Quality Management and Inspections, Pfizer, United States

Industry Update

Adrian Dana, MD

Vice President, Global Patient Safety and Risk Management, Aimmune Therapeutics, United States