Pharma R&D Today

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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” »

How to Establish a Solid PV Training Curriculum?

Posted on April 5th, 2017 by in Pharmacovigilance

There are many elements to consider when you develop a training curriculum for your PV team. A training curriculum defines which roles (rather than individuals) in a group should be trained on which processes. Here are some elements to consider if you want to maximize your training efforts in order to be efficient, compliant and inspection-ready. Continue reading “How to Establish a Solid PV Training Curriculum?” »