Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Posted on October 27th, 2015 by Neal Katz in Pharmacovigilance
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…)
Posted on October 27th, 2015 by Julio dos Anjos in Pharmacovigilance
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.