Details of GCP Inspection in Japan and

1. Introduction of PMDA 2. “Good Clinical Practice” in Japan. (J-GCP) 3. GCP Inspection Procedure in Japan 4. Details of GCP Inspection in Japan and. Overseas 5. Future Plan of GCP Inspection.

The PMDA’s GCP Inspection Methods

GCP Inspection Methods 3. Document-based Conformity Inspection and. GCP on-site Inspection 4. Current State of Overseas GCP on-site.

DTC configuration

DTC configuration. Fault. Index. Description. 0 DTC 0108: MAP pressure high 1 DTC 0107: MAP voltage low 2 DTC 0118: ECT voltage high 3 DTC 0117: ECT voltage low 4 DTC 0116: ECT higher than expected stage 1 5 DTC 0113: IAT voltage high 6 DTC 0112: IAT voltage low 7 DTC 2229: BP...



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Introduction | ich-gcp j-gcp

IRB = institutional review board; GCP = Good Clinical Practice. Table 1: Key Features of Japan’s Three-Year and Five-Year Plans 12,13. Conducting Clinical Trials in Japan: A CRO Perspective.

i · Tangorin Japanese Dictionary

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Clinical Trials | Main Provisions in GCP

J-­‐GCP* based on ICH-­‐GCP. *GCP: Guideline for Good Clinical PracOce.

Geohash - Coordinates

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