Pharma R&D Today

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How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance

Posted on March 7th, 2019 by

Adverse drug reactions can be costly and cost is just the tip of the iceberg.  This is highlighted by an FDA website which cites troubling statistics such as the 100k deaths and over 2 million serious adverse drug reactions experienced each year…

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In pharmacovigilance, effective search strings are key

Posted on February 9th, 2018 by

A key component of any pharmacovigilance strategy is building search strings that successfully identify potential adverse events, which must be reported to regulatory agencies. If the query returns too narrow a result set, adverse events may be missed. (more…)

Why a reliable FAERS searching capability is essential for pharma companies

Posted on October 27th, 2017 by

In the description of the FDA Adverse Event Reporting System (FAERS), the agency states that “voluntary and mandatory reporting plays an important role in the FDA’s post-market safety monitoring.” (more…)

Big Data and Proactive Pharmacovigilance

Posted on September 20th, 2017 by

Traditionally thought of as a post-market process, pharmacovigilance is how pharmaceutical companies monitor and address any safety issues that arise once a drug becomes available commercially. However, some companies are now thinking ahead about these potential safety concerns with what is known as “proactive PV”. (more…)

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