Clinical Trials Pharmacovigilance

Clinical trial safety is an important component of pharmacovigilance. Every medicinal product must have satisfactorily completed a clinical trial program establishing acceptable evidence of safety and efficacy before being placed onto the market. clinical trials have a regulatory definition states that any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal products, and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the objective of ascertaining its (their) safety and/or efficacy.The exact nature of these pre-registration trials will depend on several factors including the drug itself; the particular disease or indication it has the potential to treat; and the patient group studied.

 

 

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