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Pharamcovigilance and IT | Medicine

September 11th, 2009 Leave a comment Go to comments

As the focus on drug safety regulation and patient safety is increasing, the need to make the systems involved in pharmacovigilance more organized and standardized is also increasing.  The pharmaceutical industries and government organizations involved in medicine quality assessment and production are constantly demanding for technologies that produce advanced and accurate results in the process of monitoring and assessing drugs.  IT sector is playing a vital role in addressing such demands.

pharamcovigilance and it medicine

pharamcovigilance and it medicine

The IT can help pharmaceutical companies to standardize their procedures for safety management across different products and geographical boundaries.  They can make pharmacovigilance process effective in many ways including safety surveillance detection, minimize risks in management of data and assist in report submission.

Many IT industries provide tools that can assist companies in improving the quality of a report based on the features of the case and its compliance with various regulator

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y authorities.  Some statistical and mathematical tools allow easy and systematic examination of adverse events.  Some IT tools have been instrumental in enhanced detection of existing signal detention cases.  This is done by assessing patterns and events associated with inter-drug reactions.  By doing this possible cases of adverse reactions may be determined.

Most process involved in pharmacovigilance involves elaborate reports. A lot of time is spent in making these reports.  Moreover,

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Title › Pharamcovigilance and IT | Medicine

the data involved in the pharmacovigilance processes is very large and there is a chance of making mistakes in preparing reports involving such large amounts of data.  By using electronic data interchange standards, companies can design electronic standards for the transmission of regulatory information.  This can assist importing, exporting, submission of safety reports and also track submission of acknowledgements and notifications.  In this way, IT sector is helping coordinate and manage pharmacovigilance processes effectively.

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