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Monday, June 26 • 1:30pm - 2:30pm
#125: Enhancing the Quality of Safety Data Collection

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-523-L04-P; CME 1.00; RN 1.00

A key cornerstone of pharmacovigilance is spontaneous reporting, which has largely relied upon traditional approached to data collection. Technology now gives the opportunity to significantly improve the data collected at source, and also how vigilance teams engage with stakeholders. In this session, colleagues from FDA will highlight opportunities arising from their active surveillance program while MHRA will present their vision for future data collection to enhance patient safety.

Learning Objectives

Discuss opportunities discovered through active surveillance programs; Describe the vision for future data collection to enhance patience safety

Chair

Alison Cave, PhD

Speaker

MHRA Update
Phil Tregunno

CBER’s Biologics Effectiveness and Safety (BEST) Initiative: COVID-19 Bivalent mRNA Vaccines Safety Surveillance
Richard Forshee, PhD

AI Automation Update
Raymond Kassekert, MBA


Speakers
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 →
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 →
avatar for Richard Forshee

Richard Forshee

Deputy Director, OBPV CBER, FDA, United States
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products... Read More →
avatar for Raymond Kassekert

Raymond Kassekert

Senior Director PV Systems, GSK, United States
Ray is Senior 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 Transcelerate... Read More →

Monday June 26, 2023 1:30pm - 2:30pm EDT
Room 205 BC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session