Good Clinical Practices: The New ICH E6 Standard

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Good Clinical Practices
The New ICH E6 Standard

Every clinical trial operator will feel the impact of the major revision of the ICH E6. The revision imposes new guidelines to use state-of-the-art technology ... create changes in trial design, conduct, oversight, recording and reporting ... and all the while, continue insisting on highest standards of human protection and data integrity.

And that’s just for openers. Also slated for updating: Standards regarding electronic records and essential documents to boost trial quality.

As with all such documents, the guidelines are complex and technical.

Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. You will learn about:

  • New definitions or enhancements to existing glossary terms

  • How information should be recorded, handled and stored

  • Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting

  • How to provide training and adequate resources to maintain quality management and risk management

  • An increased focus on risk-based monitoring

  • And much more.

Good Clinical Practices: The New ICH E6 Standard gives you an understanding of how the evolution of technology has changed the focus of Good Clinical Practices and how to keep up with the changes.

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Who Will Benefit

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers
  • Compliance Staff
  • Clinical Quality Auditors
  • Quality Assurance Personnel

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