Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Posted on December 16th, 2015 by James Dunstan in Pharmacovigilance
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…)
Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?
Posted on November 16th, 2015 by Joyce de Langen in Pharmacovigilance
An adverse drug reaction (ADR) is defined as any response to a medicinal product which is noxious and unintended. ADRs are a major public health problem, accounting for up to 5% of all hospital admissions and 28% of the emergency visits. Of all hospitalized patients, 5% experience an ADR during the hospitalization (more…)