Getting The Balance Right: Companies Juggle UK QPPV & National Contact Person Roles
A senior MHRA inspector explains the nuanced differences between the newly created UK roles of qualified person for pharmacovigilance and national contact person to help companies position the two individuals appropriately within their organizational structures.
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The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations.
Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.