EMA WANTS COMMENTS ON NEW PHARMACOVIGILANCE RISK ASSESSMENT ADVICE
March 1st, 2016
PHARMACOS have been asked to comment on a first major update to its good pharmacovigilance risk assessment advice. The changes are based on experience gained since the European Medicine Agency’s (EMA) pharmacovigilance risk assessment committee (PRAC) started its operations, and follows a review of pharmaco risk management plans. The new advice clarifies what a risk management plan should focus upon regarding a product’s life cycle. An EMA note explained: “This will help to ensure that a risk-proportionate planning of activities directs resources to areas ...
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