Pharmacovigilance – What it Means

Having to process more cases, faster and with higher compliance will increase costs if you don’t improve your safety

Pharmacovigilance (PV), relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products during the clinical trials development process and post-approval, focuses heavily on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy.

Therefore, in order to identify the hazards associated with pharmaceutical products and to minimise the risk of any harm that may come to patients, companies must conduct a comprehensive drug safety and Pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

In light of the continued growth and proliferation of available data received from patients and healthcare providers via Pharmacovigilance agreements, as well as other sources such as medical literature, social media and online channels, PV is facing tremendous pressures to process (in some cases) many thousands of cases per year with high levels of accuracy and compliance, faster and at lower cost.

Explic8 Limited consultants can help you transform your safety processes – improving compliance, data quality and efficiency while reducing cost and complexity.

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