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Ethimark — Rooted Ethics Through Generation

Webinar

Pharmacovigilance in a Changing Regulatory Landscape

Our safety experts discuss evolving expectations for signal management, aggregate reporting and PV system oversight.

Webinar45 min session

Health authorities continue to raise expectations for how marketing authorisation holders detect, assess and communicate safety information. This session looks at what that means in practice.

Topics covered

  • Signal management workflows and documentation
  • Aligning PSUR/PBRER and DSUR timelines
  • Oversight of PV partners and licensees
  • Keeping the PSMF current and inspection-ready

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