The Arab Pharmacovigilance Guidelines

Topics

• Quality management systems
  • Quality management of PV systems
  • Quality control, quality assurance, and quality management
  • Quality and training
  • The QP PV and quality management
  • QA and quality management and internal audits
• An Introduction to the new PV Structure
  • The interaction of the modules A comparison to the EU modules
  • The new modules
• Pharmacovigilance inspections
  • Types of inspection
  • The purpose of the inspection
  • Re-inspections
  • Inspection ndings
• The Pharmacovigilance Systems Master File
  • The QP PV and the PV master le
  • Licence submissions and the PV master le
  • Control/management of the PV master le
• Risk Management Plans
  • The RMP purpose
  • ICH E2E - pharmacovigilance planning
  • Updating the RMP
  • The RMP format
  • RMPs and REMs
• Pharmacovigilance audits
  • Audit scheduling and risk
  • The purpose of company audits
  • Audit findings and their corrections - root cause analysis, corrective action plans, completion and re-audits
  • Audit outputs and ndings
• PSURs2
  • Objectives of the PSURs
  • ICH E2F and ICH E2C (R2) - DSRRs and PSURs/PBRERs
  • The format of the PSUR
  • Risk benefit analyses in PSURs
  • Mapping Signals and Risks to the PSUR
• Adverse Reaction Reporting
  • Special situations
  • De nitions
  • Expectedness and causality
  • Triage - seriousness
  • Electronic ADR reporting local and International
  • Expedited reporting
  • ICH E2D - post marketing safety
  • Follow up of cases
  • Case closure
  • Literature ADR reporting
• Signals and their management
  • Signal validation
  • What is a signal?
  • Signal assessment
  • Signal analysis and prioritisation
  • Actions to be taken

Who should Attend

Anyone involved in pharmacovigilance and regulatory activities including:

• Local QP PVs
• Pharmacovigilance case processing
• Drug safety managers
• Medical directors
• PSUR writers
• QA auditing
• Any company managers and licence holders