FDA’s PQ/CMC and KASA Initiatives

September 18, 2020 10:00–11:00 Eastern Time (US & Canada)

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/

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