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Compliance and Modernisation

The new ICH Good Clinical Practice (GCP) E6 Addendum Revision 2 (E6 R2) is the biggest amendment of the international guideline for over 20 years. The update was finalised in November 2016 and became effective in the EU on 14 June 2017, meaning organisations running clinical trials in this region should now be compliant with the new requirements.

However, in January 2017 – just two months after the new guideline was finalised – many were surprised when ICH announced that an even greater change is planned. The extra revision is being added to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.

Further Modernisation

ICH is proposing further updates to E6 R2 in what they are calling a ‘renovation’ – the scope of these further suggested changes will include clinical trial design, planning, management and conduct of clinical trials (1).

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Dr Laura Brown is Managing Director of a leading international training and quality assurance consultancy specialising in the pharmaceutical industry. She delivers a broad range of technical and management courses and consultancy for pharma, covering project management, ICH GCP R2, CAPA and clinical trial regulations. Laura is also Course Director, MSc Clinical Research, School of Pharmacy, Cardiff University, UK.
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