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