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Monitoring literature for Benefit-Risk Evaluation: a Life-Time Responsibility

Posted on January 15th, 2016 by in Pharmacovigilance

Monitoring worldwide experience

The purpose of drugs is to cure or alleviate symptoms of disease. However, drugs do not only have therapeutic effects, they may¬†also cause adverse drug reactions (ADRs). Continue reading “Monitoring literature for Benefit-Risk Evaluation: a Life-Time Responsibility” »

Are we expecting too much from the EMA’s MLM service?

Posted on December 16th, 2015 by in Pharmacovigilance

ema logo
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. Continue reading “Are we expecting too much from the EMA’s MLM service?” »

Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?

Posted on November 16th, 2015 by 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 Continue reading “Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?” »