MHRA

Preparing for the ICH E6 Revisions

Monday, May 1, 2017

In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.

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Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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