The range of global regulations and standards requiring monitoring can vary from company to company depending upon their target therapeutic area and product composition and, with the advent of software and AI embedded solutions, require regulatory affairs professionals to actively monitor an ever-increasing volume of content around the design, manufacture, sale, import, distribution, and post market activities. Failure to identify updated regulations and to meet the new requirements can result in fines and penalties, stop shipments and importation issues, and damage relationships with regulators and customers. Supporting professionals with automated solutions for the tracking of global regulations and the creation of impact assessment plans can yield significant benefits by optimizing the ability to address regulatory change in real time and provide a single source of truth when tracking a company’s progress in meeting updated/ new regulation(s). Further enhancing end-to-end regulatory surveillance with Generative AI can increase the quality of remediation plans and timeliness of a company’s compliance to regulatory change.
Learning Objectives:
Understand the challenge of monitoring regulations and standards and how the advent of software and AI embedded solutions, require regulatory affairs professionals to actively monitor an ever-increasing volume of content around the design, manufacture, sale, import, distribution, and post market activities.
Learn how automated solutions for the tracking of global regulations and the creation of impact assessment plans can yield significant benefits.
Understand how enhancing end-to-end regulatory surveillance with Generative AI can increase the quality of remediation plans and timeliness of a company’s compliance to regulatory change.
