The DIA 2020 Annual Meeting Is Now Virtual. ArisGlobal will be front and center with presentations covering both Safety and Clinical perspectives in Life Sciences process management.

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.

Advanced computing methods can be used for safety monitoring and early detection of potential signals of vaccine-related adverse events. These methods work by mining open-access active-moiety databases and vast scientific literature with clinical case studies.

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.

This is the second in a three-part blog series on National Pharmacovigilance systems and the role of technology in bridging the gaps in pharmacovigilance of regulatory authorities around the world.

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.