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FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct
Session Chair(s)
Representative Invited
FDA, United States
Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.
Learning Objective : Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight to he importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.
Speaker(s)
Industry Perspectives
Michael Torok, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Quality Assurance Programs
Health Canada Perspective
Debbi Fox
Health Canada, Canada
Compliance and Enforcement Specialist
MHRA Perspective
Jason Wakelin-Smith
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Expert GCP Inspector and Head of Compliance Expert Circle
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