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Wednesday, June 19 • 4:30pm - 5:30pm
#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-669-L04-P; CME 1.00; RN 1.00

Artificial intelligence solutions may support and enhance human decision-making and information processing throughout pharmacovigilance. This session aims to outline best practices and potential pitfalls in their use.

Learning Objectives

Recognize key challenges in assessing artificial intelligence solutions and interpreting evaluations of their performance; Describe some best practices for critical appraisal of artificial intelligence solutions; Identify the need for consideration of human computer interactions.

Chair

Jim Barrett, PhD, MSc

Speaker

MHRA Update
Phil Tregunno

FDA Update
Monica Munoz, PharmD, PhD

Industry Update
Andrew Bate, PhD, MA



Speakers
JB

Jim Barrett

Senior Data Scientist, Upsala Monitoring Centre (UMC), Sweden
Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... Read More →
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Monica Munoz

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →


Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session