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Monday June 15, 2026 2:30pm - 3:30pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00

The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.

Learning Objectives

Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports; Describe a practical framework for critically appraising of AI models and systems, with focus on risk based approaches, human oversight, validity and robustness, transparency, data privacy, fairness and equity and governance.

Chair

Phil Tregunno

Speaker

Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC

Panelist
Beth Anne MacEntee Pileggi, BSN, MBA

Panelist
Walter Straus, DrMed, MD, MPH, FACP


Speakers
avatar for Niklas Noren

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden
Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →
avatar for Beth MacEntee Pileggi

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States
Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... 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 →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

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