Pharma R&D Today

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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. (more…)

French ePharmaDay 2015: New EU Clinical Trial Regulation and Data Transparency

Posted on November 24th, 2015 by in Pharmacovigilance

On 16 April 2014, the new EU Clinical Trial Regulation on medicines for human use was adopted. The purpose of the new Clinical Trial Regulation is to create an environment that is favourable for conducting clinical trials, with the highest standards for patient safety, within the EU. (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 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…)

Pharmacovigilance: Rethinking Literature Monitoring and Review

Posted on October 27th, 2015 by in Pharmacovigilance

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…)

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