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#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Speakers
avatar for Ana Sengupta

Ana Sengupta

Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in global regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in... Read More →
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop

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