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adverse event reporting

This page shows the latest adverse event reporting news and features for those working in and with pharma, biotech and healthcare.

Sarepta investigating mistakenly submitted Duchenne therapy report

Sarepta investigating mistakenly submitted Duchenne therapy report

The report was submitted to the adverse event reporting system, a post-marketing surveillance database for approved therapies. ... The adverse event report in question detailed a case of rhabdomyolysis in a participant in Sarepta’s SRP-9001-102 study.

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  • AI is transforming pharma R&D – now it can transform pharma marketing AI is transforming pharma R&D – now it can transform pharma marketing

    adverse event reports. ... Chatbots can proactively signpost adverse event reporting channels, while questions submitted can be automatically exported to pharmacovigilance (PV) teams each day for review and PV identification.

  • Crossing the digital divide between big pharma and real-world patients Crossing the digital divide between big pharma and real-world patients

    approval can be slow and adverse event reporting can be cumbersome. ... Key tactics include having a watertight social media standard operating procedure (SOP) including a content approval process, a bank of pre-approved responses, an adverse events

  • Up close and personal Up close and personal

    In spite of the lingering concerns and uncertainty around adverse event reporting, even for the more cautious companies, being left out may well present a bigger risk than treading the unfamiliar

  • Does safety sell medicines? Does safety sell medicines?

    in knots with strict rules regarding adverse event reporting. ... The adverse event information collected in the web portal is in turn sent to the company immediately.

  • A rough guide to... advisory boards A rough guide to... advisory boards

    Compliance Diligence with 'Fair market value', disclosure and adverse-event reporting builds trust.

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