Agenda
9:00 AM — 9:15 AM
9:15 AM — 9:30 AM
Opening Remarks10:00 AM — 10:30 AM
Retrospect and Prospect of India GCP11:00 AM — 11:30 AM
EMA and National GCP Inspection: Systems and Procedures11:30 AM — 12:00 PM
GCP Audit & Observation Metrics12:00 PM — 12:30 PM
ICH GCP addendum Overview1:30 PM — 2:00 PM
Triggers for Inspections and Selection of Inspections2:00 PM — 2:30 PM
What to Expect during Regulatory Inspections3:00 PM — 4:00 PM
Case Study - GCP Inspection - EMA & EU Member State4:00 PM — 5:00 PM
Case Study - BE Laboratory5:00 PM — 5:30 PM
9:00 AM — 9:30 AM
Role of Ethics Committee in driving GCP Compliance at trial sites9:30 AM — 10:00 AM
India USFDA's Focus on Data Integrity - Lesson Learned10:30 AM — 11:00 AM
GCP as a Quality Standard in Clinical Research11:00 AM — 11:30 AM
GCP Inspections and Inspection Findings11:30 AM — 12:00 PM
GCP Inspections & Inspection Findings - EMA Perspective12:00 PM — 12:30 PM
GCP Inspections at the Sponsor Site and Findings Identified2:00 PM — 2:30 PM
Root Cause Analysis: When Something Goes Wrong4:00 PM — 5:00 PM
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