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OC vigilance

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Pharmacovigilance of medicinal products for veterinary use

Our company offers the following services in this area to carry out the task described in the current legislation:

  • Support on the design and implementation of pharmacovigilance system
  • Audits
  • Development and maintenance of the description of the pharmacovigilance system
  • Preparation and updating of Standard Operating Procedures for Pharmacovigilance (PNTs)
  • Permanent support on Pharmacovigilance-related matters
  • Immediate notificaton of updates and new regulatory requirements for pharmacovigilance
  • Preparation, review and / or update of the following documents:
    • Periodic Safety Update Reports (PSURs)
    • Risk Management Plans
  • Search and review on the world-wide scientific literature.
  • Comprehensive management of suspected adverse reactions including:
    • Reception and direct contact with reporters
    • Initial triage
    • VedDRA Coding
    • Causality assessment (ABON)
    • Veterinary assessment
    • Data Entry in Databases
    • Notification to health authorities, partners, headquarters, etc..
    • Tracking cases
    • Monitoring tasks due to special situations
    • Data Reconciliation
  • Pharmacovigilance Training
  • Contract Review
  • Technical translations