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PSMF Template Suite

$399.00

Templates with instructions for generation of a full pharmacovigilance system master file and kick off the PSMF project in the organization

Document Description

All documents include proposed comprehensive content examples you can adapt as needed in standard tools like word or powerpoint.

Main section document templates (word)

  • Section I – Qualified Person Responsible for Pharmacovigilance
  • Section II – Organisational Structure of Marketing Authorization Holder
  • Section III – Sources of Safety Data
  • Section IV – Computerized Systems and Databases
  • Section V – Pharmacovigilance processes
  • Section VI – Pharmacovigilance System Performance
  • Section VII – Quality System

Annexes templates (word)

    • Annex A – Qualified Person Responsible for Pharmacovigilance
    • Annex B – Organisational Structure of Marketing Authorization Holder
    • Annex C – Sources of Safety Data
    • Annex D – Computerized Systems and Databases
    • Annex E – Pharmacovigilance processes
    • Annex F – Pharmacovigilance System Performance
    • Annex G – Quality System
    • Annex H – Products
    • Annex I  – PSMF revision log

 

Kick off meeting, internal presentation sample template

 

SPS document 1.8.1 sample template