Pharma R&D Today

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Crisis Prevention in Pharmacovigilance

Posted on October 12th, 2016 by in Pharmacovigilance

One of the challenging situations that Pharmacovigilance functions will have to manage one day or another is a pharmacovigilance crisis. Continue reading “Crisis Prevention in Pharmacovigilance” »

Biosimilars and Pharmacovigilance: What You Need to Know—and Do—Now

Posted on April 26th, 2016 by in Pharmacovigilance

A few weeks ago, the US FDA approved Inflectra (infliximab-dyyb), a biosimilar to infliximab. This is the second US biosimilar approval, suggesting others may soon be on the way—good news for companies with biosimilars pending approval and in development. Continue reading “Biosimilars and Pharmacovigilance: What You Need to Know—and Do—Now” »

Are we expecting too much from the EMA’s MLM service?

Posted on December 16th, 2015 by in Pharmacovigilance

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At the beginning of September 2015, the EMA launched the Medical Literature Monitoring (MLM) service. I recently read the EMA’s MLM launch phase closure report in addition to information from a recent EMA information day and have highlighted some key points below. Continue reading “Are we expecting too much from the EMA’s MLM service?” »

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