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Debates on Pharmacovigilance – What’s new and trending

Posted on March 2nd, 2017 by in Pharmacovigilance

Fleming’s Pharmacovigilance & Risk Management Strategies Forum is always an excellently organized event, attended by industry leaders, policy makers and legislators. Continue reading “Debates on Pharmacovigilance – What’s new and trending” »

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” »

PV Poll: Processing of EMA MLM Data

Posted on March 16th, 2016 by in Pharmacovigilance

Over the past few months, we have posted blog entries about the EMA Medical Literature Monitoring (MLM) program, including a review of the EMA Annual Update and impressions of the launch phase closure report. Continue reading “PV Poll: Processing of EMA MLM Data” »

Validation: The importance of search formulas in Literature Monitoring

Posted on February 29th, 2016 by in Pharmacovigilance

A reasonable number of Market Authorization Holders (MAHs) have no ready answer to justify why they use a specific search formula for each specific product when Audit or Inspection time comes: Continue reading “Validation: The importance of search formulas in Literature Monitoring” »

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