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GDPR in Pharmacovigilance

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  • Hari
    23/04/2018 07:48
    Hello, The query is very broad in scope and is being raised with a view to obtain standard practices for GDPR preparation and planning within the Pharmacovigilance department. In addition to the redaction of patient and reporter's information (prior to the source document reaching the PV department), are there standard practices from the operations, systems and technical (safety database) standpoint to ensure full adherence to GDPR? Thank you.
  • Shaun Hastings
    27/06/2018 10:38
    As far as standard practices. PIPA (Pharmaceutical Information & Pharmacovigilance Association) have provided interim guidance on UK Data Protection in Post-Marketing Pharmacovigilance (link below). I am not sure if this answers your query as this is specific to post-marketing, but many of the "principles" could be transferred to other PV settings. (https://www.pipaonline.org/Interim-Guidance-Notes-on-UK-Data-Protection-in-Post-Marketing-Pharmacovigilance)
  • Almas
    10/09/2018 14:00
    Could you please share the best source to refer regarding GDPR requirement with special focus or applicability for PV related activities.
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