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Some pharmaceutical companies treat their drug safety surveillance activities as an exercise in compliance rather than as an integral part in ensuring the well-being of the patients taking their products. Pharmacovigilance can seem like a burden and a chore rather than a necessary part in running a pharmaceutical company. Yet the benefits of an effective [...]
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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 [...]
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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 [...]