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Recorded Webinar
Risk Based Approach to the Management and Monitoring of Clinical Studies : How to make it happen
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, much confusion exists around its principles, and even more confusion exists about the appropriate way to implement QRM and QbD.
In this webinar we give first an overview of the current QRM and QbD activities and initiatives of regulators, academia and industry and then we will review the principles of QRM and QbD.
A main part of this seminar will focus on the essential 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 webinar will end with a review of new global initiatives such as ACRES (www.acresglobal.net) that aims at the streamlining of the clinical trial process and thus supports streamlining processes in clinical trials.
Learning Objectives:
- QRM & QbD initiatives by Regulators such as FDA, EMA and MHRA.
- QRM & QbD initiatives of academic organizations such as CTTI, ADAMON and OPTIMON
- QRM & QbD initiatives by supranational organizations such as OECD and WHO
- Introducing and explaining a key QbD concept: the design space
- Understanding when and why errors can be tolerated and why perfection does not need to be achieved
- Why change management is the key to success when planning to move to a risk based approach
- Re-inventing monitoring, on-site monitoring, source document verification and auditing
- Planning the journey
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