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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…)

EMA’s Medical Literature Monitoring: Shakedown or Shakeup

Posted on October 27th, 2015 by in Pharmacovigilance

Although, quite a lot of existing flows have to change and new ones have to be implemented, there are, also, quite a lot of benefits, most of them for EMA, and some, not so obvious, for the MAH’s. Of these last ones, many are found by looking at the information, now made available by EMA, as an information professional in a pharmacovigilance context, as well as a pharmacovigilance analyst in an information rich environment.

Read more about EMA’s Medical Literature Monitoring

 

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