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Building a balanced search formula for pharmacovigilance and literature monitoring

Posted on March 21st, 2017 by in Pharmacovigilance

Adverse drug reactions are an important risk for patient safety and have significant impact on the costs of health systems. A rise in number of diseases has consequently led to a rise in number of drug consumption, which has also brought about an increase in the number of adverse drug events and drug toxicity cases. Continue reading “Building a balanced search formula for pharmacovigilance and literature monitoring” »

Building PV SOPs: Where to start?

Posted on March 17th, 2017 by in Pharmacovigilance

Having a set of operating standards defined through Quality Documents (QDs) is the only route to compliance and performance. QDs are defined as documents such as Policies, SOPs, Work Instructions (WINs), Manuals, Charters and Memo to File. Continue reading “Building PV SOPs: Where to start?” »

Easing the Pain in Monitoring Literature for Adverse Drug Events

Posted on September 20th, 2016 by in Pharmacovigilance

Over the past year, we have heard about the various challenges associated with the cumbersome task of monitoring scientific literature for adverse drug events (AE) from thought leaders on this blog. Pharmacovigilance professionals have written about the literature monitoring and review process, the recent EMA Medical Literature Monitoring initiative, and the importance of literature search strategies. Continue reading “Easing the Pain in Monitoring Literature for Adverse Drug Events” »

Compliance Metrics for Pharmacovigilance Activities

Posted on August 19th, 2016 by in Pharmacovigilance

Measuring the compliance of a defined set of variables is key for functions like pharmacovigilance, where there is intense reporting to different regulatory and non-regulatory entities with strict regulations and high inspection risk. Continue reading “Compliance Metrics for Pharmacovigilance Activities” »

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