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Descrição da editora
The EMEA introduced the new pharmacovigilance legislation from 02 July 2012. With this Volume 9A is replaced by the good pharmacovigilance practice guidelines(GVP) initiated by the EMEA.
Adverse drug reaction now refers to all undesirable events that have occurred in a patient that are "noxious and unintended". This means that in addition to events that are occurring at proper dose and dosage regimen, those events that occur due to medication error, misuse, abuse and off-label cases should also be reported.
Pharmacovigilance starts from the clinical trial stage and continues throughout the life cycle of the drug. The process of collection of safety information about a drug begins in phase one of the clinical trial, and continues after approval.
The principles and practice of pharmacovigilance for students & professionasl includes FDA,EMEA, IME, SUSAR,MedDRA,Narrative writing , Career Questions and more.