EU pharmacovigilance legislation troubleshooting

In Regulation and Compliance by aliceLeave a Comment

Summer is finally here in the UK and reminding us all that July and the associated EU pharmacovigilance legislation deadline is creeping closer and closer. With the bulk of preparations for the approaching deadline underway it is important to know where to turn for any last minute questions or to clarify any confusion.

The MHRA has a great website that is a one stop shop for pharma to troubleshoot any problems or sanity check the changes that are happening around them. The categories that they have separated the changes into are

Audit and inspection

PSUR

Risk minimisation, RMP and post authorisation studies

ADR reporting and signal management

Communications and transparency, including web portals

A good little tool to use!

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