“I KNOW ICH E6 (R2) COMPLIANCE INSISTS ON A RISK-BASED APPROACH TO RUNNING MY TRIALS, BUT HOW AM I GOING TO IMPLEMENT THIS AND REALIZE THE VALUE?”
This is the question on everyone’s mind and one that we’ve addressed many times with Sponsors & CROs. This comprehensive two-part on-demand webinar series answers all the questions you’re likely to have about ICH E6 (R2), Risk-Based Study Execution (RBx)/ Risk-Based Quality Management (RBQM) and where the process, people and technology elements are taking us in the future.
What’s Covered in the recordings?
The Different Approaches to Ensure ICH E6 (R2) Compliance
- ICH E6 (R2) – what is expected of you and why.
- An overview of the unique situation where regulations insist on us getting more resource and cost-efficient through compliance.
- Ways to approach the implementation of Risk-Based Quality Management.
- How much should I rely on your CRO partner to drive the new methodology and how much should you own internally.
- The functional areas are affected by this new methodology.
- The tangible cost savings from a reduction in on-site monitoring and SDV.
Measuring the Value of Compliance with ICH E6 (R2) and Implementing a Risk-Based Approach to Study Execution (RBx), Best Practice, and the Role of Analytics and Machine Learning.
- How to put a price on data quality.
- How to facilitate the Risk Assessment process.
- How to use Key Risk Indicators (KRIs) to control known risks.
- How to use Quality Tolerance Limits (QTLs) to help identify systematic issues that could impact patient safety or the reliability of trial results.
- Best practices for documenting risks and corrective actions?
- The future of Risk-Based approaches using Machine Learning and AI.
- How Risk-Based approaches are moving beyond ‘monitoring’ and now include areas such as Risk-Based Data Management & Review.
- How are regulators harnessing a Risk-Based Approach (to site inspections) and where they will see value.
If you would like a copy of the slides used in the sessions, please send an email to email@example.com.