Since 2017, the International Society of Pharmacovigilance has held thought-provoking seminars on Intelligent Automation in Pharmacovigilance. Offering a unique, highly focused, scientific and interactive two-day event, 30 speakers across the pharma and technology services industry were invited to speak on this engaging topic.
In recognizing the need for aligned language in describing and validating various intelligent automation technology in PV, TransCelerate has proposed a classification system of AI-based systems for use by our industry in validating systems with health authorities. After evaluating the existing regulation for each class of system, we propose an extension of existing guidance to ensure appropriate validation of AI-based static systems in PV utilizing ISPE’s GAMP® 5 methodology. In doing so, we can begin to articulate best practices for health authorities to use when validating these systems to ensure they are fit for purpose. We will discuss our recent investigations into the various components of AI-based validation and assurance, including: planning, requirements and specifications, data selection, model development, acceptance testing, and modification (re-training) triggers.
- Danielle Abatemarco, Scientific Publications Lead, WorldWide Patient Safety, Bristol-Myers Squibb
- Oeystein Kjoersvik, Product Owner, MSD – Czech Republic