Wednesday, March 22, 1:30pm – 3:00pm
INTERPHEX Innovation Stage, Booth 1170, Exhibit Hall
Post-Approval Changes: Addressing Regulatory Roadblocks
Changes to a manufacturing process during the lifecycle of a drug product are inevitable. New regulations, materials suppliers, and facility and equipment updates can contribute to improved processes. The complications and costs of implementing these changes, particularly in a global environment, may discourage companies from updating facilities and systems, contributing to a downward quality spiral. This session will examine ongoing challenges with implementing post-approval changes, efforts to educate and harmonize national and regional regulations, and will feature an approach to address post-approval changes during the initial application process.
