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In recent years Regulatory Authorities across the globe have increased their focus on pharmacovigilance and drug safety activities. The result has been stringent regulations, rigorous scrutiny of the pharmacovigilance systems of pharmaceutical companies and severe penalties in the event of non compliance. For companies with a global footprint, there is now a critical need to comply with the disparate regulations across the wide range of countries where they operate. Good pharmacovigilance can preempt the escalation of safety issues through label changes and changes in the mode of use, and, on occasion, provide early safety signals to avert crisis. Pharmacovigilance is therefore critical to the long term success of every pharmaceutical product.
The WHO defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. GVK BIO has the expertise to operationalize and execute all systems and processes implied by this definition.
Please click on the links to the right to know more. |
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