FDA’s PQ/CMC and KASA Initiatives
The webinar will summarize the current and future status of the PQ/CMC project, and its relation to the KASA initiative. This will include FDA’ efforts to date, including a proof-of-concept with several PhRMA firms, and attempts to harmonize IDMP terminology. Recent ICH and HL7 FHIR developments also will be discussed.
Post webinar info:
Link to NCI EVS where PQ/CMC is published ... https://evs.nci.nih.gov/ftp1/FDA/PQCMC/