“I know ICH E6 (R2) 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 webinar series will answer all the questions you have about ICH E6 (R2), Risk-Based Study Execution (RBx) and where the process, people and technology elements are taking us in the future.
Here’s what you can expect from the sessions:
What are the Different Approaches to Ensure ICH E6 (R2) Compliance and What is the Right Methodology for Me?
- ICH E6 (R2) – what is expected of me and why?
- An overview of the unique situation where regulations insist on us getting more resource and cost-efficient through compliance.
- What are the various ways to approach the implementation of Risk-Based trial management?
- How much should I rely on my CRO partner to drive the new methodology and how much should I own internally?
- Which functional areas are affected by this new methodology?
- How do I know whether I’m succeeding in implementing what the regulators expect of me?
- The tangible cost savings from a reduction in on-site monitoring and SDV – just how much can I save?
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 do I put a price on the improvement of data quality?
- How do I 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.
- What are the best practices to document risk and corrective action?
- 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 will they see value?
Please note, upon registering, you will automatically be enrolled for both sessions. If you can’t make both, don’t worry we will be sending out the recordings upon conclusion of both sessions.
We will be running the series twice to cater to different timezones:
Part One: 10 AM BST/ 11 AM CEST on September 12, 2019
Part Two: 10 AM BST/ 11 AM CEST on September 19, 2019
Part One: 10 AM EDT on September 10, 2019
Part Two: 10 AM EDT on September 17, 2019
Please note, upon registering, you will be enrolled in both sessions for the series that you selected. If you can’t make both, don’t worry, we will be sending out the recordings upon conclusion of the sessions.
If you have any questions, please contact Gemma.email@example.com