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 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 of the major health authorities now adopting the guidance, companies running trials under the guidance are expected to be complaint for all new studies and major study revisions.

This free webinar, focusing on quality management, will allow companies to quickly gain an understanding of the changes required by the guideline and what they are going to mean for them in real terms regarding their quality management practices, systems, and staff.

The webinar is aimed at any person or company who has not yet started to consider the R2 changes or their implementation. It is also designed to be an effective way for senior management to gain a rapid understanding of the changes and to understand the starting point for implementation.

This webinar is free to all employees of companies actively engaged in the running of clinical trials.

The webinar will cover the following:

    • Mar 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 and how it will impact your company.

  • What were the adoption timelines?
  • What are the key components of the changes and what do they mean in terms of processes, roles and technology?
  • What is the relationship between the changes and risk-based monitoring?
  • What will it take to be compliant with the changes?
  • What will it take to implement the changes?
  • What solutions can be adopted to enable compliance?
  • How are TRI accelerating the process of R2 compliance?

To Register, click here