Increasing and complex regulatory requirements, Globalization of Pharmacovigilance, Public and Politic expectations: The new proactive approach of Risk Management
If you want to ensure the safety of your products and the compliance to regulation you need:
If you want to ensure the safety of your products and the compliance to regulation you need:
- Management of the safety for the clinical trials
- Design of the safety plan
- Training of the investigators and CRAs
- Reception and treatment of the SAE declarations
- Submission of the SUSARs to the Authorities
- Periodical Safety Reports
- SUSARs transmission to the investigators
- Data Safety Management Board (DSMB)
- Safety and data management databases reconciliation
- Interface and support with the sponsor’s Safety department