Monthly Archives: July 2016

Jul 2016

FDA RBM Guidance MindMap

By | 2016-11-16T18:35:30+00:00 July 27, 2016|Blog|0 Comments

Which elements must a Risk-based Monitoring (RBM) plan must contain? What are the sponsor responsibilities regarding clinical monitoring? What kind of monitoring methods does the FDA suggest? To answer these questions, please, explore the MindMap of the "Guidance for Industry. Oversight of clinical Investigations - A Risk-Based [...]

Jul 2016

ICH GCP Addendum E6 (R2) (Explanation Video from ICH)

By | 2016-11-16T18:35:31+00:00 July 8, 2016|Blog|0 Comments

Source: http://www.ich.org International Council for Harmonisation (ICH) first time since 17 years is undertaking ground-shaking changes to Good Clinical Practice (GCP) guidelines. These changes take effect on November 1, 2016. In the 22 minute video above it is described how the new upcoming ICH [...]

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