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Advanced Pharmacovigilance Training Course: Examples from the Real World

Advanced Pharmacovigilance Training Course: Examples from the Real World

on 24-26 May, 2022, in Riyadh – Saudi Arabia

Who should attend?

  • Pharmaceutical industry personnel from areas including drug safety, clinical research, medical affairs, and regulatory
  • Staff from regulatory authorities
  • Professionals who are interested in pharmacovigilance

Outlines:

Regulatory & legal aspects in pharmacovigilance with practical examples

  • How to prepare & maintain a sufficient Pharmacovigilance System Master File (PSMF)
  • The Role of the Qualified Person Responsible for Pharmacovigilance & how to be a successful QPPV
  • How to be prepared for audits and inspections in pharmacovigilance

Pharmacovigilance Data Management:

  • How to manage safety signals including detection, assessment, evaluation & further processing
  • Identify the key elements of periodic safety update reports requirements with practical aspects
  • How to process the expedited Individual Case Safety Reports (ICSRs) including their causality assessment

Pharmacovigilance and Pharmacoepidemiology Methods:

  • How to evaluate a single case report & case series
  • How to evaluate observational studies
  • How to review PASS protocol including identify knowledge gap, select the proper study design, address limitations, measure the interventions and outcomes

Risk Minimization Plans

  • Describe the components of the risk management plan including evaluation and implementation
  • How to evaluate effectiveness of risk minimization measures

Training Cost

6785 SAR