Monitoring System
- During registration procedure all PhV documents will be submitted to EPVC.
- Upon release of the product on the market, physicians, patients, healthcare teams and other caregivers can report side effects and safety concerns.
- All of our employees participate in PhV training, to ensure effective collection of safety data within our organization.
- BORG will transmit all valid Individual Case Safety Reports (ICSRs) promptly to EPVC after the initial receipt of the information within:
- 15 calendar days (serious ICSR)
- 90 calendar days (nonseriousness ICSR)
Additionally, we take active measures to analyze all collected safety data:
Periodic Safety Update Report – A comprehensive report submitted to the authorities that includes safety data and analysis of risk-benefit profile.
Risk Management Plan – Based on a specific product’s safety profile, BORG suggests routine/additional activities to monitor, minimize or prevent important identified, potential risks and missing information.