Safety Blogs

On November 28, 2017, ArisGlobal held a webinar with DIA, “How Automation Can Deliver the Holy Grail in Safety: Achieve Productivity, Compliance and Quality”.  In this webinar, we posed a few questions to the audience, and came up with some interesting information.  We took this and spent some thinking about what this means to our clients in the PV ecosystem.

Life sciences companies confront increasingly stringent requirements on safety signal detection and risk management. Regulatory authorities are taking steps to further safeguard patients by requiring companies to take more comprehensive steps to assess and monitor the benefit-risk balance of their products.

For many companies, signal detection in drug safety pharmacovigilance ranks closely behind regulatory submissions and case management as a key activity because it helps to proactively monitor a product’s risks that come to light from tracking the data submitted to internal and external drug safety databases and platforms.

As different regulatory authorities have different timelines for adoption of these standards, E2B(R2) E2B(R3) will have to coexist. But having to operate two solutions creates huge complexities, unless you find a solution compliant with both. ArisGlobal LifeSphere Safety MultiVigilance is the only drug safety database solution provider thus far to provide full compliance to E2B R2 and E2B R3 standards for both import and export.

Artificial intelligence (AI), machine learning, deep learning, natural language processing – in short, cognitive computing, is changing the pharmacovigilance world…

Safety departments at Marketing Authorization Holders & Regulatory Authorities are under pressure from all sides. They must constantly stay on…

Artificial intelligence (AI), machine learning, deep learning, natural language processing – in short, cognitive computing, is changing the pharmacovigilance world as we know it. While there’s a lot of talk about how AI will affect jobs, where it will have the most powerful impact is on the quality of work and the speed at which manual tasks can be accomplished.

As the outsourcing trend continues to grow, many biopharmaceutical and pharmaceutical companies find themselves needing to partner with CROs (contract…