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Wednesday, June 30 • 10:00am - 11:00am
#309 L: From Opportunity to Strategy: Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-599-L04-P; CME 1.00; IACET 1.00; RN 1.00

Intelligent automation can transform the ICSR process. We discuss how to pair opportunities with available technologies for this process, and how a validation strategy may vary based on the proposed automation for a given ICSR process step.

Learning Objectives

Recognize available PV automation technologies as they relate to opportunities and the current PV technology landscape within the ICSR process; Describe how to plan future use of intelligent automation based on risks, benchmarking, and potential benefit; Describe how to educate colleagues on possible opportunities, areas worth exploring for further transformation, possible technology solutions, and validation strategy.

Chair

Raymond Kassekert, MBA

Speaker

Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process
Sameen Desai, MBA, MS

Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process
Neal Grabowski, MBA, MS

Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process
Griselda Saldana, MSc



Speakers
NG

Neal Grabowski

Director, Pharmacovigilance & Patient Safety, AbbVie, United States
Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.
avatar for Sameen Desai

Sameen Desai

Senior Director, Head Digital Insights and Innovation, Bristol-Myers Squibb Company, United States
avatar for Raymond Kassekert

Raymond Kassekert

Senior Director PV Systems, GlaxoSmithKline, United States
Ray is Senior Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the Transcelerate... Read More →
avatar for Griselda Saldana

Griselda Saldana

Director, Global Safety, Systems and Information Management, Amgen, United States
Griselda Saldana, joined the Amgen Global Safety Records Management team in September 2003. Over her 16 year tenure at Amgen she’s had increased responsibly in support of the safety database. She leads a team of Safety Data Analysts that provide routine and ad hoc safety data outputs... Read More →


Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Workshop