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OC vigilance

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Pharmacovigilance of medicinal products for human use

Our company can offer all possible solutions to meet current pharmacovigilance legislation.

  • Consultancy on the design and implementation of Pharmacovigilance systems
  • Audits
  • Preparation and updating of Standard Operating Procedures for Pharmacovigilance (PNTs)
  • Development of the CCSI (Company core safety information)
  • Permanent consultancy in Pharmacovigilance issues
  • Immediate notification of updates and new regulatory requirements for pharmacovigilance
  • Active search for security alerts associated with active ingredients published by health authorities
  • Development, revision and / or update of the following documents:
    • Periodic Safety Update Reports (PSURs)
    • Expert Reports
    • Critical assessment of the risk-benefit balance
    • Risk management plans
    • Summary of the Pharmacovigilance System Master File
  • Preparation and maintenance of the Pharmacovigilance System Master File
  • Registration with Eudravigilance (Pharmaceutical companies).
  • Implementation and review of literature search in the world-wide scientific literature
  • Comprehensive management of suspected adverse reactions, including:
    • First reception and direct contact with reporters
    • Initial triage
    • MedDRA Coding
    • Medical Assessment
    • Data Entry in database
    • Notification to health authorities, partners, headquarters, etc.
    • Tracking cases
    • Monitoring tasks due to special situations
    • Data Reconciliation (headquarters, partners, quality complaints, medical information,…)
  • Introduction of information of medicinal products in the XEVMPD (Extended Eudravigilance Medicinal Product Dictionary)
  • Review of protocols of post-authorization studies
  • LOPD Consulting and Type Code
  • Training in Pharmacovigilance
  • Review of Pharmacovigilance contracts and SDEA (safety data exchange agreement)
  • 24-hour phone contact
  • Technical translations
  • Support in validation and implementation of databases