darpana_n@hotmail.co.uk

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  • in reply to: Global PV SDEA/contracts database #42809

    Hi,

    Yes, it would be GxP applicable and needs to be validated.
    Not aware of any software but a database can be built on a SharePoint – which will just need to validated by your internal IT and will be cost effective.

    in reply to: Patient Identifiers vs valid reports – MHRA #42808

    Hi,

    As per the guidance v2 “Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority” released by the MHRA, there is no modification to the term identifiable patient. So the GVP module definition of identifiable patient applies for UK as well.

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