LATAM Pharmacovigilance
The team at FP CLINICAL PHARMA can help your company in developing a GOOD PHARMACOVILIGANCE PRACTICES PROGRAM according to your specific needs.
THE GOOD PHARMACOVILIGANCE PRACTICES PROGRAM was designed as a quality system based on national and international guidelines and includes the investigation, detection, assessment, validation, monitoring, reporting and archiving of adverse events of the products during commercialization.
Service Packs
BASIC
Pharmacovigilance notification management
Use of the F.P. Platform VigiPharma
Notification report
24/7 Communication
Out-of-office professionals
SUPERIOR
Search for safety information in scientific literature
Identification of safety signs
Prospect Review
Training and in-house workshops
Preparation for audits and inspections
Security agreements between companies
Update of the organic and documentary structure
CONSULTANCY
How to set up your Pharmacovigilance Unit
Preparation of Pharmacovigilance Master File
Good Pharmacovigilance Practices
Implementation of Quality System in Pharmacovigilance
Carrying out training
Review and Analysis of Management Plans
Modification of prospectuses
SPECIALS
Preparation of Security reports (IPS/PSUR/PBRER)
Risk Management Plans (PGR/RMP)
Active Pharmacovigilance Plans
