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Good Pharmacovigilance Practice Guide PDF

231 Pages·2008·2.29 MB·English
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Description:
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions.The MHRA has identified a need for writing and publishing a guide to "Good Pharmacovigilance Practice". This text complements current legislation and guidance, and provides practical advice about achieving an appropriate system of pharmacovigilance.
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