• +34 987 261 064
LeonResearch.Pharmacovigilance

VETERINARY PHARMACOVIGILANCE

 

We understand veterinary pharmacovigilance as the science and activities related to the detection, evaluation, understanding, and prevention of suspected adverse events or any other problem related to a veterinary drug.

At León Research we provide a high-quality pharmacovigilance service in each study, creating a specific plan for the safety system to be followed for each project, adapted to the Guides for Good Pharmacovigilance Practices included in the legal framework of the European Union 2019/6, which entered into force on January 28, 2022.

 

CONTACT US

MAIN VETERINARY PHARMACOVIGILANCE SERVICES

  • Veterinary QPPV in Europe

  • Preparation and maintenance of the PSMF

  • Risk management plan including signal detection

  • Record of adverse events in EVVET

  • Adverse event reports

  • Literature research

  • Management and internal audits of the PV quality management system

  • Training plan in PV

Leon Research PV Veterinaria

PLEASE FILL IN THIS FORM FOR MORE INFORMATION

    VETERINARY PHARMACOVIGILANCE SERVICES

    HOW CAN LEÓN RESEARCH HELP VETERINARY HEALTH PROFESSIONALS?

    • Preparation of the Pharmacovigilance System Master File (PSMF)

    • Initial training on PMSF management

    • Pharmacovigilance System Master Plan Maintenance

    • Initial registration of suspected adverse events and additional data collection

    • Preparation of reports of adverse events and additional data to present to the health authorities

    • Assessment of causality in all adverse events

    • Carrying out internal audits of the Pharmacovigilance system

    • Monitoring of the quality, integrity and content of the information registered in the pharmacovigilance system, including the information reported to the European Union Database (EVVET) and search for duplicates.

    • Record of adverse events in EVVET

    • Document management and archiving system for relevant documentation

    • Risk Management Plan: including signal detection, continuos benefit/risk monitoring and a communication plan

    • Pharmacovigilance training plan for all personnel involved in the commercial, quality, distribution, auxiliary personnel, etc.

    • Literature research

    • Preparation of a model agreement on pharmacovigilance with drug distribution entities (commercial veterinary distributors)

    Ready to work together?

    Leon Research is a pharmaceutical services provider based in Spain, Italy and Portugal

    LET'S CHAT