+ 971 2 555 9394

PROGRAM OUTLINE

Pharmacovigilance Short Course

Duration: 2 days

Audience:

  • Medical affairs professionals
  • Clinical Research professionals
  • Clinical Safety staff
  • Regulatory affairs personnel
  • Research and Development teams
  • Risk Management specialists
  • Compliance specialists

Content:

  • Introduction to PV
  • Importance of AE reporting
  • Process flow
  • Sources of ADRs
  • Causality and Expectedness
  • Lack of Efficacy
  • Expedited reporting
  • The Pharmacovigilance system in India
  • The PV regulations in EU
  • Qualified Person for Pharmacovigilance (QPPV) requirements
  • Development Safety Update Reports

On completion, participant will:

  • Demonstrate an understanding of the importance of safety reporting
  • Demonstrate an awareness of the correct reporting requirements that ensure patient safety
  • Demonstrate an understanding of the roles and responsibilities of individuals responsible for safety reporting
  • Demonstrate an ability to achieve timely submission of AE reports generated inhouse


Contact us at + 91 98672 67661 or info@pharmawisdom.com

Comment on this article on       
Pharmacovigilance, adverse events, AE reporting systems, case processing, causality, expectedness,
QPPV, safety update reports, expedited reporting.