Global Regulatory Requirements for Pharmacovigilance

 The Pharmacovigilance Global Regulatory Requirements course covers the key components of US and EU legislation, US and EU safety reporting regulations, including publications by the Council for International Organizations of Medical Sciences (CIOMS) and guidelines from the International Conference on Harmonisation (ICH).

Course Content:

• Legalities – US
• Legalities – EU
• Penalties for Non-Compliance
• Matrix of Safety Regulations
• FDA Regulations
• FDA Regulation for IND safety reporting
• IND Annual Report
• Literature Reporting
• International Conference on Harmonisation (ICH)
• ICH Topic Codes and Reports
• CIOMS
• Key EU Components
• EU Member States
• What is Europe? EU, EEA, EFTA
• EudraVigilance – Pre-Marketing Requirements
• EudraVigilance – Post-Marketing Requirements
• EUDRACT
• EU Clinical Trial Directive
• Volume 10
• Qualified Person for Pharmacovigilance (QPPV) requirements
• Development Safety Update Report
• European Signaling Regulations
• EU Pharmacovigilance Legislation
  • Pharmacovigilance fees
  • GVP modules and implementing measures
  • Quality systems
  • Audit and inspection
  • PV System Master File (PSMF)
  • ADR reporting
  • Periodic Safety Update Reports
  • Signal management
  • EudraVigilance monitoring
• Quiz on Module 2