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Application of Regulatory Guidance & Good Clinical Practices (GCP) to Ensure Clinical Data Integrity
Application of Regulatory Guidance & Good Clinical Practices (GCP) to Ensure Clinical Data Integrity

Our Price: $395.00

Product Code: WB-7260

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About the Product
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


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

Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:

  • GCP Quality Assurance
  • GCP Compliance
  • Quality Assurance
  • Data Management
  • Clinical Data Management

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