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Top 5 Challenges to ICH E6 Rev 2 Compliance

  Let’s look at the intent and purpose of the revision … The revised Addendum is proposed to modernize ICH E6 and enable implementation of innovative approaches to clinical trial design, conduct and management that will better ensure subject protection and data quality. This is a significant and positive step, but we will only realize the benefits if we…

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ICH E6 Revision 2 Approved

First new regulatory Members of ICH, key global good clinical practice guideline revisions agreed The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug…

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Setting Your Own Standards for ICH E6 Rev 2 Implementation

  The “eagerly awaited” revision to ICH E6 is going to provide a clear message about the expectation for how a clinical trial is conducted in today’s world compared to the world of the mid 1990’s when the first version was adopted by the three ICH regions. ICH E6 is by definition a guideline and therefore provides guidance, i.e….

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ICH E6 Revision 2 – What Does It Mean In Practical Terms?

Nowadays we all use multiple electronic systems in clinical trials. Consequently, we need SOPs in place to define/control how these are developed, used, accessed and secured to ensure of the integrity of the data we produce.   We’ve been doing corrective and preventive actions (CAPA) for years but Revision 2 emphasizes the need to analyse the “root-cause”…

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ICH E6 Revision 2 – “Begin With The End In Mind”

  Regulators will soon require sponsors and CROs to demonstrate that they have effectively anticipated, managed and mitigated risk during the course of each study.   Identifying and then setting your end point as the target is the most likely way to achieve success.  We have to know where we want to end up in order to plan and…

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