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Webinar: ICH E6 (R2): Training and Certification

May 3, 9:30am – 11:00am ET This webinar is a comprehensive review of the changes included in revision 2 of the ICH E6 guidance. It is designed for anyone who is looking for a broad understanding of the changes, or is in the process of adopting the changes in readiness for compliance. Delivered by our in house expert, Tammy…

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Webinar: ICH E6 (R2): A Practical Guide to Risk Assessment, Evaluation and Implementing Risk Controls

April 10, 9:00am – 11:30am ET Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and yet it is something we find many…

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Webinar: ICH E6 (R2) Overview

March 27, 9:00am – 10:00am ET The session will highlight the key changes made in ICH GCP E6 (R2) which was implemented by the EMA on 14 Jun 2017 and added to the FDA guidance documents on 1 March 2018. This webinar is for anyone wanting a high level understanding of what R2 is, why it has been implemented…

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Operationalizing RBM – Free RBM webinar

(Expired) Successful risk-based monitoring extends well beyond just risk detection. The clinical R&D industry needs to deliver on the promise of quality improvement and cost reduction both operationally and from a regulatory perspective.  We must be able to show evidence that due planning and oversight has taken place during a study by building an audit trail of the way…

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OPRA – A practical RBM demonstration

(Expired) This webinar will give a brief summary of the concept and purpose of the OPRA RBM platform, followed by a detailed system demonstration of the features and functions. We will wrap up with an open question and answer session, where you will be able to address questions to TRI’s management team. Please follow the link below to register…

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OPRA – technology walk through and latest features

(Expired) Learn how OPRA has been designed to support the four pillars of RBM: Identify, Manage, Mitigate and Report. See the new features in the latest evolution of OPRA, and learn how TRI are continually improving the system in order to support any company wishing to benefit from quality oversight and risk-based monitoring. Who should attend: Existing customers of…

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Protocol Risk Assessment and Designing Site Quality Risk Indicators

(Expired) Within this webinar, we will: – Illustrate the process of using the outputs of protocol risk assessment to identify protocol risk indicators – Illustrate the process of designing protocol risk indicators – Explore the characteristics of good indicators of site quality risk – Explore the practical application of surrogate risk indicators in RBM

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Free Webinar – ICH GCP E6 Revision 2

(Expired) ICH GCP E6 revision 2 is due to be finalized this summer and implemented later this year. The impact on any company running clinical trials is going to be significant. Companies need to start planning now to ensure adequate time for change management and implementation to occur. This free webinar, focusing on quality management, will allow companies to quickly…

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Protocol Risk Assessment Made Simple

(Expired) Protocol Risk Assessment – limited attendance Why is this webinar so important? Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and…

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Free Webinar – 7th Feb 2017 – Using technology to support ICH E6 (R2) compliance

The video below shows TRI’s CIO Chad Finch introducing the webinar: This webinar is free to attend for anyone who is directly involved in the planning and execution of clinical trials.   WHO SHOULD ATTEND? Anyone who is already running clinical trials using the principles of quality management  as defined by ICH E6 (R2) and risk-based monitoring,  or anyone…

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