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EMA Yearly Update on MLM – highlights and next steps

Posted on January 19th, 2016 by in Pharmacovigilance

EMA¬† Pharmacovigilance Programme Update Issue 6 ‚Äď Preparing for Business Change

Since July 2014, EMA provides quarterly Pharmacovigilance Programme Updates to Marketing Authorisation Holders (MAHs). Continue reading “EMA Yearly Update on MLM – highlights and next steps” »

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?” »

Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?

Posted on November 16th, 2015 by in Pharmacovigilance

An adverse drug reaction (ADR) is defined as any response to a medicinal product which is noxious and unintended. ADRs are a major public health problem, accounting¬†for up to 5% of all hospital admissions and 28% of the emergency visits. Of all hospitalized patients, 5% experience an ADR during the hospitalization Continue reading “Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?” »