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2nd ICH E6(R3)
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COMPUTERIZED SYSTEMS
Thursday September 5, 2024 12:15pm - 12:45pm EDT
Illustrate the Changes Pertaining to the Development and Validation of Clinical Systems
Define the purpose of each system as it relates to the specific clinical trial and who as responsibility
Develop clinical systems for GCP requirements, no more repurposing non-clinical systems
Solicit input from patients, HCPs and all end-users on system design
Evaluate new expectations on user management and security
Examine changes in the timeframe for system validation
Thursday September 5, 2024 12:15pm - 12:45pm EDT
Available On-Demand - Must Participate LIVE to Engage with Speakers
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