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Recorded Webinar
How To Reconcile ICH GCP With RISK BASED Monitoring Approaches
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Quality Risk Management (QRM) and Quality by Design (QbD) are hot topics and many sponsors – commercial as well as academic ones – have initiated steps to implement such an approach. However, still much confusion exists around its principles, how these relate to ICH GCP, and even more confusion exists about the appropriate way to implement QRM and QbD. A proposal has been submitted to the ICH Secretariat for an update of the ICH GCP E6 Guidelines but do sponsors need to wait for such an update to effectively implement a Risk based Monitoring (RbM) or rather a Risk based Study Management approach?
This presentation will provide a better understanding on how ICH GCP relates to RbM and also what sponsors need to change in their processes and planning approach to ensure that when a clinical trial applies an RbM strategy regulatory requirements and expectations of inspectors are met.
A main part of this seminar will focus on the essential GCP requirements and steps to be planned and implemented to make a risk based approach a success. As part of this review we will also discuss in detail common pitfalls when implementing a risk-based approach and how these could be avoided.
The presentation will cover the following areas:
- How ICH GCP relates to Risk based Monitoring (RbM) approaches.
- How the “traditional” study management approach needs to change when a sponsor moves to a RbM strategy.
- How an RbM strategy must change strategic clinical development and study planning.
- How on-site monitoring and auditing need to change in a RbM environment.
- What are current RbM sins.
Who should attend
The presentation is directed at clinical operations, study directors, quality assurance staff members, project managers and as well as investigators and other sponsor representatives.
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