The ICMRA PQKM project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project
Learning Objectives
Understand the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
