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#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-620-L04-P; CME 1.00; RN 1.00

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speaker

Panelist
Jie Li

Panelist
Susan A. Oliveria, DrSc, MPH

Panelist
Alice Hsu, MPH


Speakers
avatar for William Blumentals

William Blumentals

Head of Pharmacoepidemiology, Specialty Care, Sanofi, United States
William has spent over 20 years supporting and leading epidemiology teams in biopharma, including roles in pharmacovigilance and medical affairs. Currently, he co-leads the real-world data access and availability workstream with TransCelerate and is the Head of Pharmacoepidemiology... Read More →
avatar for Alice Hsu

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States
Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →
JL

Jie Li

Associate Director for RWE, OSE, CDER, FDA, United States
SO

Susan Oliveria

Vice President, Global Head of Epidemiology and Scientific Affairs Peri- and Pos, Thermo Fisher Scientific, United States
Dr. Oliveria's career as a pharmacoepidemiologist spans more than 25 years in academia, industry, and non-profit settings. She is trained as a pharmacoepidemiologist, having received her Doctor of Science from the Harvard School of Public Health. In her current role she leads the... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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