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Monday, June 16
 

11:00am EDT

A Regulator's View on the Future Vision for Pharmacovigilance
Monday June 16, 2025 11:00am - 12:00pm EDT
Component Type: Forum
Level: Basic

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

3:45pm EDT

Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
Monday June 16, 2025 3:45pm - 4:45pm EDT
Component Type: Session
Level: Basic

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PhD, MS, RPh, FISPE

Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PhD, MS


Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
avatar for Saad Shakir

Saad Shakir

Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
 
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