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Monday, June 28 • 2:30pm - 3:30pm
#127 SL: Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Jamie Wilkins, PharmD


FDA Update
Jason Bunting, PharmD

Industry Update
Bertha V Ferrer, MSc, RPh

Industry Update
Adrian Dana, MD

avatar for Jamie Wilkins

Jamie Wilkins

Senior Director, Head - Risk Management Center of Excellence-Worldwide Safety, Pfizer Inc, United States
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →

Bertha Ferrer

Senior Director, Head of Quality Management and Inspections, Pfizer Inc, United States
Bertha Ferrer ,Senior Director , Head of Quality Management and Inspections , Pfizer Inc- Based in Peapack, NJ, Bertha l leads a team that collaborates with the Pharmacovigilance Organization to create strategies for inspection readiness and support of inspections and audits globally... Read More →
avatar for Jason Bunting

Jason Bunting

Science Policy Analyst, OCD, CDER, FDA, United States
Jason Bunting, PharmD, is a Science Policy Analyst in Drug Safety Operations (DSO), in the Office of the Center Director, Center for Drug Evaluation and Research. DSO is responsible for the management of significant and timely drug safety issues, as well as the creation and oversight... Read More →
avatar for Adrian Dana

Adrian Dana

Vice President, Global Patient Safety and Risk Management, Aimmune Therapeutics, United States
Dr Adrian Dana is the VP of Global Patient Safety and Risk Management for Aimmune, a leader in the development of treatments for food allergies. In this role, she is building an innovative safety organization to support the development of these new therapies. Her past positions include... Read More →

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session