admin @ # 8 Comments
1.) SAVING MONEY
It costs money to recruit staff and keep them permanently. It costs a LOT of money to set up a pharmacovigilance system. For example a full working drug safety database on its own can cost in excess of £200,000 before the staff to run it are even notified of vacancies.
2.) PROVIDING FLEXIBILITY
A lot [...]
admin @ # 6 Comments
ROUTINE DATA PROCESSING:
This includes receiving the safety data from the public and from health professionals, triage of routine cases to determine seriousness, entry of the data into a validated pharmacovigilance database, coding the narrative and providing medical review and surveillance of cases.
EXPEDITED REPORTING:
All reports of serious adverse events have to be reported to regulatory authorities [...]
admin @ # No Comment Yet
Preparation of Detailed Description of Pharmacovigilance System
Every marketing authorisation in the EU has to come with a detailed description of the pharmacovigilance system being employed by the pharmaceutical company in addition to any risk management plans that will be employed. This has to include proof that there is a QP and that the QP is [...]