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San Diego Convention Center

Jun 16, 2024 7:00 AM - Jun 20, 2024 3:00 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2024 Global Annual Meeting

Join us at the premier life sciences conference, celebrating our 60th anniversary! Discover 180+ sessions on Cell and Gene Therapy, Decentralized Clinical Trials, AI, ICH, and more. Get ready to tackle challenges, improve skills, network, and drive change for healthcare at DIA2024.

Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking

Session Chair(s)

Ana  Sengupta, MBA, MS, RAC

Ana Sengupta, MBA, MS, RAC

Associate Director Regulatory Affairs CMC

Mirum Pharmaceuticals, Inc., United States

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 Objective : 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.

Speaker(s)

Ana  Sengupta, MBA, MS, RAC

Designing Regulatory Intelligence Framework: Powered by Critical Thinking

Ana Sengupta, MBA, MS, RAC

Mirum Pharmaceuticals, Inc., United States

Associate Director Regulatory Affairs CMC

Susan  Carino, MBA, MS, PMP, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence

Susan Carino, MBA, MS, PMP, RAC

Mammoth Biosciences, United States

Director, Program Management

Aditi  Khurana, MBA, PMP, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence

Aditi Khurana, MBA, PMP, RAC

Summit Therapeutics, Inc., United States

Director, Project Management

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