Elsevier whitepaper

Meeting pharmacovigilance and medical device post-market surveillance requirements

Elsevier R&D Solutions for Pharma and Life Science: extracts from Elsevier’s whitepaper  THE FUNDAMENTALS OF MONITORING LITERATURE Monitoring literature for product citations would be an impossible task if not for modern research informatics solutions. Corporate, academic and government pharmaceutical and medical research facilities produce in excess of 20 terabytes of data per day. Even with only a fraction of this data …

Guest Post: ‘Safety signal action still down to human judgement, conference hears’

This article was provided by APM Heatlh Europe from their coverage of the recent World Drug Safety Congress Europe 2013. LONDON, Sept 12 (APM) – Major drug companies make decisions on whether to act on safety signals using human judgement, despite the vast amount of pharmacovigilance data and statistical tools now available, a conference heard. Unlike clinical trials, where statistical …

Institute of Medicines new drug safety recommendations

The Institute of Medicines, the evidence-based advisory committee for policymakers, health professionals, the private sector, and the public has released a press release with advice for the improved oversight of drug safety of marketed medicines by the FDA.Drug safety is critical throughout the lifecycle of a drug but the increasing size, time length and diversity of the patient pool when …

What does the new European pharmacovigilance legislation mean for pharma?

Pharma is still on the cusp of the EU pharmacovigilance legislation changes that are part of the drive to improve patient safety in Europe. I wanted to discuss the next milestones in the EMAs European legislation changes and what pharma should be looking at. The EMA amendments to the way drug safety is monitored and reported in Europe are well …