New EU, Vigilance Practices, Legislation, Drug safety

New EU Good Vigilance Practices Legislation

At the 2014 World Drug Safety Congress Americas, Mariska Kooijmans, Biogen Idec, gave a presentation on “New EU Good Vigilance Practices Legislation.”

Download and learn:

  • Background and goals EU PV Legislation
  • EU GVP Modules – major changes
  • PRAC
  • PV Quality Requirements
  • Pharmacovigilance Systems Master File (PSMF)
  • Biogen Idec approach to implementation
  • Summary

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