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#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-634-L04-P; CME 1.00; RN 1.00

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Chair

Luis Pinheiro, PharmD, MSc

Speaker

Panelist
Timothe Menard, PharmD, MSc

Panelist
Tala Fakhouri, PhD, MPH


Speakers
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

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