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#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-562-L04-P; CME 1.00; RN 1.00

The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.

Learning Objectives

Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.

Chair

Mayur Patel, PharmD

Speaker

Panelist
Suranjan De, MBA, MS

Panelist
Andrew Bate, PhD, MA

Panelist
Phil Tregunno

Panelist
Jeremy Jokinen, PhD, MS


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 →
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... 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 →
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 →
Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

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