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Thursday, June 20 • 9:15am - 10:15am
#414: Regulatory Affairs of the Future: Is Now

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-689-L04-P; CME 1.00; RN 1.00

Global regulatory affairs is a critical function at the key interface between the innovation from our pipelines and patients. The world around us is changing very rapidly leading to implications and opportunities for regulatory affairs. We must evolve. But how?

Learning Objectives

Identify what global changes are leading to an evolved regulatory affairs organization; Discuss what skillset global regulatory affairs professionals of the future will need.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

FDA Update
M. Khair ElZarrad, PhD, MPH

Academic Update
Maria Florez, MA

Industry Update
Nicole Mahoney, PhD


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Maria Florez

Maria Florez

Senior Consultant, Tufts Center For the Study of Drug Development, Tufts Univers, United States
Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... 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 →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum