GCP Inspection Harvest – The PPH plus Newsletter
In its latest Newsletter, PPH plus provides a summary of the GCP inspections findings recently published by the EMA’s GCP Inspectors Working Group (IWG) and the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) for inspections conducted in 2016.
The provided GCP inspections metrics reveal the need of improvement of quality management in clinical trials mainly at the sponsor and CRO side. PPH plus has refreshed its Knowledge Center with the “All About RBM” section to offer its customers a full overview of useful risk-based quality management system tools, guidelines and implementation strategies available online.
The periodical refers to the revised EMA guideline on first-in-human clinical trials and the agency’s new mandatory form to be used by Marketing Authorization Holder (MAH) for submitting data generated to satisfy post-authorization measures (PAMs) for centrally authorized products.
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