Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Posted on October 27th, 2015 by Neal KatzPharmacovigilance
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 AnjosPharmacovigilance
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.
Posted on October 23rd, 2015 by Thibault GeouiChemistry
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.
About this Blog
The Elsevier Pharma R&D blog provides insight and opinion on topics related to pharmaceutical research and development, namely: big data, target identification, new drug discovery, drug safety monitoring, risk mitigation and regulatory compliance. We serve the community of chemists, scientists, drug safety specialists, educators and students interested in pharmaceutical R&D.
Editor’s note: The views and opinions expressed are those of the author and do not necessarily reflect the views of Elsevier, its affiliates and sponsors or its parent company, Reed Elsevier.