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Prescription event monitoring PEM
Has the patient suffered an ADR? assessment of drug
The interface between the medical profession and
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ABPI ADR reporting adverse drug reactions adverse event assess associated case-control studies causality chapter cimetidine clinical trials cohort studies Committee on Safety data sheet database described diagnosis disease drug interactions drug reactions ADRs drug safety drug safety monitoring drug surveillance department drug's edited effects efficacy evaluation factors Glaxo hospital identify IDSD important incidence investigator's brochure investigators ISBN manufacturer marketed drugs medical profession number of patients occur phar pharmaceutical company pharmaceutical industry pharmacists Pharmacoepidemiology pharmacologically Pharmacovigilance PMS studies possible post-marketing surveillance practolol pre-marketing prescription problems product licence published pulmonary embolism rechallenge regulatory authorities reporting doctor reporting of ADRs reports of adverse reports of suspected responsibility risk role safety data safety issues Safety of Medicines serious specific spontaneous reports suspected ADRs suspected adverse reaction suspected reactions therapeutic therapy toxicity type A ADRs type B reactions worldwide Yellow Card scheme