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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 Continue reading “Can We Apply Leadership Skills to Writing Pharmacovigilance SOPs?” »

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. Continue reading “The Importance of the Safety Management Plan for Clinical Trials” »

The Liabilities of Pharmacovigilance Activities

Posted on June 21st, 2017 by in Pharmacovigilance

There is always a risk that any Pharmacovigilance (PV) activity, even executed with the highest business and ethical standards, and with the highest compliance results, could be challenged, sometimes many years later. As a member of a PV team, you may have to one day justify your actions in front of a group of plaintiff’s lawyers, Continue reading “The Liabilities of Pharmacovigilance Activities” »

The Four Cornerstones of a Pharmacovigilance Organization

Posted on May 8th, 2017 by in Pharmacovigilance

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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