Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Taking a Balanced Approach to Monitoring Literature

Posted on September 11th, 2017 by

In a time when the focus on pharmacovigilance is greater than ever before, literature monitoring presents pharmaceutical companies with significant challenges. Pharmacovigilance groups are looking for ways to efficiently and cost-effectively manage an increasing workload while remaining compliant with regulatory best practices. (more…)

FDA Speeds Up Generic Approval Process

Posted on August 30th, 2017 by

Healthcare has been in the spotlight for much of the year so far, as Congress has wrestled with the difficult question of how to make it both better and more affordable.

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Can We Apply Leadership Skills to Writing Pharmacovigilance SOPs?

Posted on August 18th, 2017 by

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…)

Assessing DDI Risk in the Digital Age

Posted on August 9th, 2017 by

pills pic for SD case study
In their 2012 Drug Regulations, the U.S. Food and Drug Administration recommended that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development.”

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