Pharma R&D Today

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Shouldn’t pharmacovigilance be less painful?

Posted on May 26th, 2017 by

PV white board

Even with advanced information technologies, too many companies and pharmacovigilance practitioners are still living with the pain of having to rely on ineffective and outdated systems and processes. Continue reading “Shouldn’t pharmacovigilance be less painful?” »

Compliant Monitoring of Adverse Events

Posted on May 24th, 2017 by

Developing and maintaining a solid strategy for screening for adverse events is critical for every pharmaceutical company. Without one, an adverse event could be reported in scientific literature without the company knowing — and failure to report it to the regulatory authorities could result in a serious warning. Continue reading “Compliant Monitoring of Adverse Events” »

Protocol Deviations and Serious Breach Expedited Reporting

Posted on May 19th, 2017 by

Protocol deviations will occur even with the best designed clinical trial protocols and investigator training. Although minimizing such protocol breaches is an absolute mandate for Clinical Trial Sponsors, there are specific deviations (usually qualified as “major”) which require expedited reporting if they impact patient safety. Continue reading “Protocol Deviations and Serious Breach Expedited Reporting” »

The Four Cornerstones of a Pharmacovigilance Organization

Posted on May 8th, 2017 by

For small organizations, building a PV department from the ground up can be an exercise of trial and error, frustrating and costly. Being in growth mode means that there is not much time to anticipate and plan, as multiple high priorities compete for attention. Continue reading “The Four Cornerstones of a Pharmacovigilance Organization” »

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