Archemin

Advice & reporting for the chemical and pharmaceutical industries

Pharmacovigilance - Introductory Training

Half-day training on pharmacovigilance focusing on the tasks and responsibilities of the Local Contact Person for PharmacoVigilance (LCPPV) in the BENELUX.

Please subscribe to our mailing list if you would like to be informed about the next session

Send your contact details to pharmacovigilance [at] archemin.eu

Topics

Focus on the tasks and responsibilities of the LCPPV in the BENELUX.

  • Overview of general pharmacovigilance tasks according to European legislation
    • Reviewing the Good Vigilance Practice modules
    • Eudravigilance
    • What are the Pharmacovigilance obligations of the European Marketing Authorisation Holders
    • Timelines for reporting, consolidation
    • GDPR
  • LCPPV activities: Requirements for LCPPV
    • Practical organisation of the 24/7 permanence
    • How is weekly literature screening organised, how to report
  • Pharmacovigilance quality system
    • Establishing the quality system (Standard Operating Procedures & working instructions)
    • Pharmacovigilance databases
    • Interaction between the various stakeholders (Health Authorities, Drug Regulatory Affairs, Healthcare Professionals, Consumers)
    • Selecting suitable Key Performance Indicators
  • Audits
    • Preparing for audits and inspections
    • What can be expected during an audit or inspection of the Pharmacovigilance system
    • Handling audit findings: preparing and executing the CAPA plan
  • Other Pharmacovigilance tasks
    • Pharmacovigilance responsibilities and activities related to clinical trials
    • Periodic Benefit-Risk Evaluation Report (PBRER)
    • Risk Management Plans and Risk Minimisation Measures

This training will be given in English and the number of attendees is limited.

Who should attend?

  • Junior Drug Safety Officers
  • Starting Drug Safety Officers
  • All those who are interested in the tasks and responsibilities of the Local Contact Person for PharmacoVigilance in the BENELUX

Want to participate?

Send your contact details to pharmacovigilance [at] archemin.eu