Category: GCP
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US FDA GCP Inspections
Understanding the basics of a US FDA BIMO Inspection (includes useful links). The US Food and Drug Administration (“FDA”, or “The Agency”) is empowered to protect public health through, among other activities, conducting routine and targeted inspections of firms, facilities and personnel conducting clinical research with investigational drugs. To achieve…
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Rethinking GCP Documents: No More SOPs? (a lighthearted perspective)
GCP SOPs are a dry old subject at the best of times. In this article I take a lighthearted look at one new approach we may adopt to get better engagement for anyone conducting clinical research.
2Richards, Inc. 