Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider

On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.

This document is intended to provide guidance on the steps to be followed during remote pharmacovigilance (PhV) inspections of marketing authorization holders (MAHs).

Remote inspections should follow the guidelines and procedures that already exist for coordinating, preparing and conducting PhV inspections, but should take into consideration the limitations imposed by using a remote process. It is the purpose of this document to outline the specificities of remote PhV inspections by identifying the points that should be considered during the preparation, conduct and reporting of such PhV inspections of marketing authorization holders (MAHs) with centrally authorized products (CAPs) and national authorized products (NAPs).

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