New ICH E6(R3) GCP Guideline MasterClass - US edition

The current guideline at the time was outdated. Now with the revision of a clear connection to ICH E8 “General Considerations for Clinical Trials” guideline, there is a clear pathway to focusing on what matters and more freedom in trial design.
 

21-22 February, 2024, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

The ICH E6(R2) revision was the beginning of global harmonization and the modernization of clinical trials, but it lacked a link to support for clinical trial design flexibility. The current guideline at the time was outdated. Now with the revision of a clear connection to ICH E8 “General Considerations for Clinical Trials” guideline, there is a clear pathway to focusing on what matters and more freedom in trial design. The ICH E6(R3) Good Clinical Practice (GCP) guideline incorporates key concepts from the revised ICH E8(R1) Guideline and expands on the themes of Quality by Design, not using a one size fits all approach, and using a least burdensome approach to the design and conduct of clinical trials. Rather than following a checkbox mentality, critical thinking is emphasized. Additional emphasis is on selection and oversight of contract service providers, electronic system validation and security, and the need for maintaining a risk based approach throughout. With this Masterclass, learn how to successfully integrate changes into your organization and programs.

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RECOMMENDATION

Who should attend?

• Anyone involved in clinical trials
• Clinical Research Professionals
• Sponsors
• CROs
• Clinical Sites
• CRAs, Project Managers
• Clinical Operations
• Principal Investigators
• Study Coordinators
• Study Managers