Japan PMDA Inspections from a CDM/EDC Perspective

Time

Wed, Jun 17 9:00AM
W 27

Title

Japan PMDA Inspections from a CDM/EDC Perspective

Abstract Summary

ORAL PRESENTATION SCHEDULED: Wednesday, June 17 in Session #2B at 12:52 - 12:57 pm in the Exhibit Hall Poster Area (Hall A entrance)

This case study required cross-functional participation (e.g. Drug Safety, CDM, Clinical Operations, Biostatistics, Regulatory Operations and Affairs, etc.) to review and compile documentation required for the PMDA sponsor checklist as well as the PMDA Task List, including the EDC Management Sheet.

Poster Presenter

Ryan Michael Lariviere
Clinical Data Associate II,
Gilead Sciences, Inc.
United States