Pharmacovigilance Audits and Inspections Training Course 2019

Topics and Course Content

The Pharmacovigilance Audits & Inspections Training Course will cover topics such as:

  • Legal bases for PV audits and inspections 
  • Preparation for PV Audit and/or Inspection – Headquarter, Affiliate, Business Partners
  • Departments and activities that might have an impact on the PV system 
  • Audits in and outside European Union 
  • Pharmacovigilance Audit and Inspection Findings 
  • Preparation and Monitoring of CAPAs 

The content of the course is structured to encourage delegates to:

  • Work in small groups 
  • Put into practice the skills learned during the lectures
  • Pass a test in the end of the course & test evaluation
  • Consult your specific situations with experts on PV auditing in Europe and beyond
  • Share experience with PV professionals