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#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P; CME 1.00; RN 1.00

A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.

Learning Objectives

Discuss the challenges and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.

Chair

Sarah Vaughan

Speaker

Panelist
Michael Mittelman

Panelist
Peter Hjelmstrom, MD, PHD

Panelist
Lisa Wolf, PHARMD


Speakers
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre (UMC), Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
MM

Michael Mittelman

Chairman, American Living Organ Donor Fund, United States
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 →
avatar for Lisa Wolf

Lisa Wolf

Deputy Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States
Dr. Lisa Wolf joined the Division of Pharmacovigilance-I (DPV-I), Center for Drug Evaluation and Research, US Food and Drug Administration in 2016, where she served as a Safety Evaluator for gastroenterology products, followed by Team Leader covering multiple therapeutic areas, and... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Area Patient-Centered Design and Experience
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Patient-Centered Design and Experience
  • Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
  • Tags Forum

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