GUIDANCE February 2023
Compliance Inspection under PMD Act — Overview
ABSTRACT — EDITORS' SUMMARY
PMDA presentation covering how GCP compliance inspections work under the PMD Act. Covers the relationship between data reliability and evaluation, standards for application data, inspection scope, and the Office of Non-clinical and Clinical Compliance's role.
EMBEDDED PDF
METADATA
SOURCE
PDF · CANONICAL LINK https://www.pmda.go.jp/files/000251863.pdf ↗ RELATED · SAME AUTHORITY