Pharma R&D Today

Pharmacovigilance: Rethinking Literature Monitoring and Review

Posted on October 27th, 2015 by Neal Katz

Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.” Under that umbrella, government agencies in the United States, the European Union and other parts of the world have developed diverse and increasingly complex regulatory requirements. (more…)

EMA’s Medical Literature Monitoring: Shakedown or Shakeup

Posted on October 27th, 2015 by Julio dos Anjos

Although, quite a lot of existing flows have to change and new ones have to be implemented, there are, also, quite a lot of benefits, most of them for EMA, and some, not so obvious, for the MAH’s. Of these last ones, many are found by looking at the information, now made available by EMA, as an information professional in a pharmacovigilance context, as well as a pharmacovigilance analyst in an information rich environment.

Read more about EMA’s Medical Literature Monitoring

Data, Data and More Data

Posted on October 23rd, 2015 by Thibault Geoui

Read an excerpt from the Elsevier whitepaper, Big Data, Wider Mindset to discover how systems biology and systems chemistry enable a holistic view of a biological system that is more than it’s sum of molecular components.

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