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
Monday June 16, 2025 1:30pm - 2:30pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
