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Panel: Ensuring Data Reliability Under the New ICH E6(R3) Guidelines
Friday September 27, 2024 3:00pm - 3:45pm EDT
  • Explore key aspects of the new E6(R3) language around risk-based proportionate approaches to data reliability, including requirements for computerized systems validation, data handling procedures, and monitoring practices
  • Discuss strategies and best practices for ensuing compliance with the updated reliability requirements, and practical implications for quality systems, data management processes, and vendor oversight
  • Gain insight on how sponsor organizations and CROs can prepare for these changes to ensure reliable data under the new guidelines


Speakers
avatar for Michael Walega

Michael Walega

Head of Centralized Monitoring, Bristol Myers Squibb
Michael Walega is the Head of Centralized Monitoring at BMS. In this capacity, he is responsible for providing protocol teams with actionable insights to achieve higher quality, ensure that centralized monitoring processes are aligned to relevant regulatory requirements, and championing... Read More →
Friday September 27, 2024 3:00pm - 3:45pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

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