Essential GCP ICH E6 R2 Update

Published: 2-Dec-2015

19 - 20 January 2016

Course

The Rembrandt Hotel, London, UK


The draft ICH guideline for GCP E6 (R2) Current Step 2 version dated 11 June 2015 was released at the end of July 2015. This is an international guideline which will update the current ICH GCP requirements globally.

This course will cover the new guideline’s recommendations for applying advances in technology, risk based approaches for setting up and running clinical trials, increased sponsor oversight including of CROs, and enhanced requirements for recording and reporting data. These new approaches are aimed at increasing efficiency and also to reduce costs of clinical trials.

This course will enable you to meet the new international GCP standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the US, Canada and Switzerland.

Organiser: Management Forum

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