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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)
FDA Update
Jason Bunting, PharmD
FDA, United States
Science Policy Analyst, Office of the Center Director, CDER
Industry Update
Bertha V Ferrer, MSc, RPh
Pfizer, United States
Senior Director, Head of Quality Management and Inspections
Industry Update
Adrian Dana, MD
Aimmune Therapeutics, United States
Vice President, Global Patient Safety and Risk Management
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