Category: Pharmacovigilance – Blog

Smart Signal Management in Pharmacovigilance

The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on potential PV risks, as needed.  You have identified a signal…Now what? Once a signal is

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Ennov PV – An Auto-Testing Revolution

[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with respect to quality in the products that we deliver. Pharmacovigilance software is synonymous with reliability and dependability and it has

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Three steps to signal detection in Pharmacovigilance

There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand the clinical risk in light of multiple impacting factors, in a demonstrably controlled manner. Benefit/risk balance for a drug, vaccine,

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Our Journey with Scrum

[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time to reflect on our journey so far. It’s pretty obvious that implementing any new process is going to be a

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