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Wednesday, June 19 • 1:15pm - 2:15pm
#347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

Learning Objectives

Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

Chair

Ethan Chen, MBA, MS, PMP

Speaker

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Nicole Mahoney, PhD


Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
avatar for Nicole Mahoney

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States
Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   03: Data-Tech, Forum