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Monday, June 17 • 3:30pm - 4:30pm
#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

Learning Objectives

Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

Chair

Andrew Bate, PhD, MA

Speaker

Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD

Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
MP

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States
Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... 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 17, 2024 3:30pm - 4:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session