“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 to Expect from the Recordings:
PART ONE:
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 you should 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.
PART TWO:
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 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 protected]
