APPLICATION OF REGULATORY GUIDANCE & GOOD CLINICAL PRACTICES (GCP) TO ENSURE CLINICAL DATA INTEGRITY

PRODUCT INFO

Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

As pharmaceutical manufactures increasingly outsource various clinical research processes and procedures, accurate and reliable data generation from a trial’s inception to archival is increasingly critical. To mitigate instances of data inaccuracy and corruption, leading regulatory authorities have released various guidance documents and recommendations for validating clinical data integrity as a result of multiple instances involving data inaccuracies, corruption, and violations. To ensure success in clinical studies,  manufacturers must have a thorough understanding of related regulatory requirements and recommendations while taking a cross-functional approach to developing flexible clinical data integrity systems.

  • Perspective on Clinical Data Integrity (components, enablers, definitions
    • Differentiating quality from integrity
    • Systems Validation and Data Integrity in clinical development
  • Cultural Awareness and Process considerations for global an local clinical teams
    • The evolving role of Clinical Data Scientists and Stewards
    • The dawn of Digital Clinical Data
  • Guidance and feedback from regulators in the evolving clinical landscape

 

Speaker:
Thomas Haag
Global Head Digital Development & Transformation QA,
Novartis Development Quality Assurance Operations

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com

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