Pharma R&D Today

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How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance

Posted on February 26th, 2019 by in Pharma R&D

Adverse drug reactions can be costly and cost is just the tip of the iceberg.  This is highlighted by an FDA website which cites troubling statistics such as the 100k deaths and over 2 million serious adverse drug reactions experienced each year…

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Are Drug-Drug Interactions Today’s Biggest Health Threat?

Posted on October 16th, 2018 by in Pharma R&D

The use of prescription medicines is sharply on the rise. Over the past decade, the number of adults taking over-the-counter medicines has sunk, while the number of prescription drug users has increased by more than 30 percent. (more…)

Can We Apply Leadership Skills to Writing Pharmacovigilance SOPs?

Posted on August 18th, 2017 by in Pharmacovigilance

The Policies, Procedures and other Quality Documents that we use as a backbone to our daily PV activities are the fundamental references for ensuring the consistency of the execution of our activities. They also ensure adequate documentation (more…)

The Importance of the Safety Management Plan for Clinical Trials

Posted on June 30th, 2017 by in Pharmacovigilance

In a world where many operational and strategic clinical trial activities are outsourced to Contract Research Organizations (CROs), the design and content of the Safety Management Plan (SMP) will greatly influence the execution of clinical trial drug safety activities. (more…)

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