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#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration
Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P; CME 1.25; RN 1.25

This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.

Learning Objectives

Identify algorithmic innovations that address signal detection challenges in vulnerable populations; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.

Chair

Ju-Young Shin, PHD

Speaker

Recent advances in PV innovation: implementing/deploying for practical impact
Raymond Kassekert, MBA

A method for systematically retrieving pregnancy-related reports
Daniele Sartori, MSC

Panelist
Gerald Dal Pan, MD, MHS


Speakers
avatar for Raymond Kassekert

Raymond Kassekert

Executive Director, PV Systems Management, GSK, United States
Ray is Executive 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 MedDRA... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session |   03: Data-Tech-AI, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Artificial Intelligence
  • Interest Area Health Technology & AI,Clinical Safety & Pharmacovigilance
  • Tags Session

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