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Monday, June 17 • 3:30pm - 4:30pm
#153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-552-L04-P; CME 1.00; RN 1.00

Regulatory intelligence is the key to formulating regulatory strategy. We will share the application of AI and critical thinking in developing science and risk-based strategies for the development and lifecycle management of medicinal product.

Learning Objectives

Apply skills learned in this session to set up regulatory intelligence frameworks for their team and/or company; Develop critical thinking skills that are imperative to the interpretation and proper utilization of intelligence data; Identify how to setup and manage tools and processes for surveilling and monitoring regulatory changes.

Chair

Ana Sengupta, MBA, MS, RAC

Speaker

Designing Regulatory Intelligence Framework: Powered by Critical Thinking
Ana Sengupta, MBA, MS, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Susan Carino, MBA, MS, PMP, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Aditi Khurana, MBA, PMP, RAC


Speakers
avatar for Ana Sengupta

Ana Sengupta

Associate Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta is the Associate Director of Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 24 years of pharmaceutical industry experience and 14 years of direct experience in regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she... Read More →
avatar for Susan Carino

Susan Carino

Director, Program Management, Mammoth Biosciences, United States
Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
avatar for Aditi Khurana

Aditi Khurana

Director, Project Management, Summit Therapeutics, Inc., United States
Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session