Pharma R&D Today

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How to Establish a Solid PV Training Curriculum?

Posted on April 5th, 2017 by

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?” »

The Change Imperative: Finding the right balance as times change

Posted on March 27th, 2017 by

I was delighted to chair a CPD Pharmacovigilance meeting last week in Berlin. I had been asked to share perspectives from the discussions within the Pharmaceutical Special Interest group at the Chartered Institute of Ergonomics and Human Factors. Continue reading “The Change Imperative: Finding the right balance as times change” »

Building a balanced search formula for pharmacovigilance and literature monitoring

Posted on March 21st, 2017 by

Adverse drug reactions are an important risk for patient safety and have significant impact on the costs of health systems. A rise in number of diseases has consequently led to a rise in number of drug consumption, which has also brought about an increase in the number of adverse drug events and drug toxicity cases. Continue reading “Building a balanced search formula for pharmacovigilance and literature monitoring” »

Building PV SOPs: Where to start?

Posted on March 17th, 2017 by

Having a set of operating standards defined through Quality Documents (QDs) is the only route to compliance and performance. QDs are defined as documents such as Policies, SOPs, Work Instructions (WINs), Manuals, Charters and Memo to File. Continue reading “Building PV SOPs: Where to start?” »

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