POSTMARKETING PRODUCT SURVEILLANCE Meaning and
Definition
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Postmarketing product surveillance, also known as post-marketing surveillance or pharmacovigilance, refers to the ongoing monitoring and evaluation of pharmaceutical products after they have been approved for marketing and made available to the general population. It is an essential process conducted by regulatory authorities, healthcare professionals, and pharmaceutical companies to assess the safety and effectiveness of medical treatments.
The aim of postmarketing product surveillance is to detect and mitigate any potential adverse effects or risks associated with the use of a drug or medical device, which may not have been identified during the premarket clinical trials. This surveillance involves collecting and analyzing data from various sources including healthcare providers, patients, and spontaneous reporting systems.
Through postmarketing product surveillance, experts can identify and investigate adverse events, side effects, or drug interactions that were not observed during clinical trials due to the limited sample size and duration. The collected data is then evaluated to determine the severity and frequency of the events, allowing healthcare professionals and regulatory authorities to make informed decisions regarding the product's continued use or potential restrictions.
Overall, postmarketing product surveillance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle, helping to protect patient health and prevent harm caused by any unforeseen risks or adverse effects.
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