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Worried about R2 compliance?

July 12, 10:00am EDT / 4:00pm BST Our free webinar will give you the information you need and practical advice on implementation. The session will highlight the key changes made to ICH GCP E6(R2). We’ll also share with you what’s important, what you need to know and some practical steps that you can take on your R2 compliance journey….

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R2 survey results June 2018

Only 12% of companies reporting R2 readiness In June this year we conducted an industry survey on ICH E6 (R2) readiness, and had over 100 responses.  Only 12 % said they have completed their readiness programs.  Even more surprising, 27% of respondents said they haven’t even started yet. Given the adoption of R2 by EMA, FDA and Health Canada…

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Webinar: OPRA – technology that makes quality management and R2 compliance simple

June 21, 10:00am EDT / 3:00pm BST Free webinar: OPRA – making quality management and R2 compliance simple       This webinar showcases TRI’s OPRA technology platform.  Learn how OPRA supports central monitoring, RBM, quality oversight and reporting. Understand what’s new in the latest release of OPRA and what’s upcoming in the next release.    To Register, click…

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Webinar: A practical guide managing protocol risks

June 14, 10:00am EDT / 3:00pm BST Free Webinar: R2 readiness – A practical guide to protocol risk assessment, evaluation and implementing risk controls. This webinar is designed to help anyone planning to conduct protocol risk assessment and develop a quality management plan as part of ICH E6 (R2) compliance. The session will describe the regulatory context from ICH…

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Webinar: What you need to know about R2

June 7, 10:00am EDT / 3:00pm BST Everything you need to know about the key ICH GCP E6 (R2) changes. It’s for anyone wanting know what R2 is, why it has been implemented and how it will impact your company. The impact of ICH E6 (R2) on any company running clinical trials is going to be significant. With most…

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eLearning R2 Awareness Training

The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is so important, and what it means to your organization. This 90-minute course is available as a self-serve eLearning package, or an instructor led webinar. The course is targeted at individuals within Sponsor organizations and CROs that are involved in the design, conduct…

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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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R2 Implementation and CRO Oversight Case Study

Our client, a large global biopharmaceutical company had recently merged with another similar company. The QA department of the resulting company was met with the task of both integrating two quality management systems as well as preparing for ICH E6 (R2). To add further complexity to their situation, our client was also looking to streamline the number of strategic…

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The Current State of ICH E6 Revision 2

In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA…

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ICH E6 R2 Breakdown by Section

This ICH GCP Guideline Integrated Addendum Breakdown provides a quick overview of the unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the…

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