Pharma R&D Today

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Streamlining Detection Strategies for Signal Detection

Posted on September 29th, 2017 by in Pharma R&D

Widespread underreporting is often cited as a factor that curtails the analytical value of data from spontaneous reporting systems. Voluntary submission of reports is a core feature of these systems but it also means that not all events suspected to be associated with a medicinal product are documented and brought to the attention of authorities and marketing authorization holders – Continue reading “Streamlining Detection Strategies for Signal Detection” »

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

Posted on December 16th, 2015 by in Pharmacovigilance

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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?” »