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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 – Preparing for Business Change

Since July 2014, EMA provides quarterly Pharmacovigilance Programme Updates to Marketing Authorisation Holders (MAHs). (more…)

Pharmacovigilance events in different regions cover common concerns

Posted on January 7th, 2016 by in Pharmacovigilance

In December, Elsevier sponsored the 11th Annual Pharmacovigilance, Drug Safety and Risk Management conference in Brussels, Belgium and the 2nd Adverse Event Reporting and Safety Strategies Summit in Philadelphia, USA.  (more…)

Social Media Screening for ADR-monitoring – Like it or not!

Posted on December 16th, 2015 by in Pharmacovigilance

Social Media and Pharmacovigilance

Limitations of clinical trials and traditional post-marketing sources of safety information. 

Due to limitations of pre-marketing clinical trials, there isn’t much information available once a medicinal product is authorized for marketing. (more…)

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

Posted on December 16th, 2015 by in Pharmacovigilance

ema logo
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. (more…)

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