We offer pharmacovigilance services for human use and veterinary during the study and once marketing authorization is available.
PHARMACOVIGILANCE FOR HUMAN USE
Pharmacovigilance services in Spain, Italy and Portugal
We understand pharmacovigilance as the process of monitoring and evaluating the safety and benefit/risk balance of a medicinal product throughout its lifecycle, both in the clinical phases and in the marketing period.
Likewise, monitoring the safety of medical devices is essential to prevent and reduce the recurrence of incidents related to their use.
How we work at León Research:
We provide a high-quality pharmacovigilance service by creating a specific plan for the safety system to be followed in each study, adapted to the Good Pharmacovigilance Practice Guidelines included in the European Union Legal Framework.
Pharmacovigilance of medicinal products and medical devices safety is carried out under the Good Pharmacovigilance Practices, national legislations and European regulations following the highest quality standards to ensure compliance with safety requirements.
Main Pharmacovigilance Services
Pharmacovigilance for human use
Contact us for more information
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.
Main 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, continuous 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)