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PVSentinel Agency News

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Customized PV related regulatory updates from Agencies across the world

Driven by Automation, Intelligence and Digitalization

Pharmacovigilance departments need to stay updated with current and forthcoming regulatory changes across the globe. New changes and recommendations emerge almost every day, and a lack of pro-active approach only adds to the complexity. If you’re not following agency news and not referencing the most recent guidance documents and recommendations, you may be introducing unnecessary compliance risks and ultimately wasting resources.

PVSentinel News and Updates

PVSentinel News & Updates solution coupled with our Agency Intelligence consulting services will enable Pharmacovigilance teams to comply with the latest drug safety regulatory requirements and guidelines for both investigational and authorized products. Using this module, PV personnel can receive automated global regulatory news and related updates for taking critical decisions related to patient safety, quality and compliance.

Key Product Features

With PVSentinel you can confidently comply with PV regulatory guidelines, proactively manage audits and inspections, and successfully comply with PV regulations worldwide. Following is the key solution unique and automation driven capabilities:

  • Preconfigured and ready to be deployed feeds provided by agencies, utilize companies product/ license information and Artificial Intelligence technologies to identify and deliver relevant and customized recommendations (such as PRAC) and news (timelines, guidelines etc.) for you.
  • Comprehensive functionality to create action items to manage the new recommendations, compliance requirements and timelines
  • Help Pharmacovigilance people maintain Pharmacovigilance regulatory information, and where interested parties throughout the organization can have read only access
  • Inbox for consolidated incoming alerts and notifications. Create tasks on work assignment and track progress, expiry and updates
  • Insights & Analytics: Ready to use and extendable dash boards, performance indicators. Share reports in various formats PDF, ppt, through various channels

IntelliPulse, a unique signal mapping concept alerts designated users and PV leadership on signals related to products, markets and agency compliance updates and recommendations

How Do we Deliver

PVSentinel News & Updates is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.

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