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Wednesday June 17, 2026 4:00pm - 5:00pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P; CME 1.00; RN 1.00

This session will share insights into signal detection approaches across different product types, exploring how regulators, industry, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.

Learning Objectives

Describe challenges in performing signal detection activities across a range of healthcare product types, including devices, combination products, and advanced therapies; Discuss novel approaches and data sources to enhance signal detection; and identify opportunities to incorporate emerging signal detection approaches into your organization's vigilance activities.

Chair

Monica Munoz, PHARMD, PHD

Speaker

Panelist
Judith Maro, MS

Panelist
Jeffery L Painter, JR, JD, MSC


Speakers
avatar for Judith Maro

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States
Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... 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 Jeffery Painter

Jeffery Painter

Senior Director, Quantitative Leader for Safety Innovation & Analytics, GlaxoSmithKline, United States
Jeffery Painter is the Quantitative Leader for Safety Innovation and Analytics at GSK, advancing pharmacovigilance through Bayesian methods, semantic similarity, and ontology-driven analytics. He is the author of PVLens, a drug safety reference database derived from regulatory labeling... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm 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 Development & Operations
  • Tags Session

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