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DIA 2021 Global Annual Meeting

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

Jamie Wilkins, PharmD

  • Senior Director, Head - Risk Management Center of Excellence-Worldwide Safety
  • 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

FDA Update

Jason Bunting, PharmD

  • Science Policy Analyst, OCD, CDER
  • FDA, United States
Bertha V Ferrer, MSc, RPh

Industry Update

Bertha V Ferrer, MSc, RPh

  • Senior Director, Head of Quality Management and Inspections
  • Pfizer Inc, United States
Adrian Dana, MD

Industry Update

Adrian Dana, MD

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