As Pharmaceutical companies expand the number of regions within which clinical, manufacturing and marketing authorization is performed, the demands for managing regulatory change intensifies. Coupled with the growing diversity in product make-up (biologics, cell and gene therapies, companion diagnostics, delivery devices, digital health), the depth and breadth of regulatory changes can cripple Quality and Regulatory functions. The process of managing regulatory change is burdensome, costly, and prone to compliance risk. The task of changing SOPs to comply with regulatory change in multiple global regions is anything but simple, and industry leaders look to change the paradigm completely.
Although regulatory functions have not widely applied artificial intelligence to streamline and automate processes, AI and digital automation have the potential to support and transform this business need. Ultimately, this will allow pharmaceutical companies to react to changes in regulatory requirements in a nimble and highly efficient manner, to reduce compliance missteps and avoid risks and fines. In this presentation, we discuss a new approach that leverages technology, AI and automation to streamline SOP monitoring and updating and increase efficiencies. After this webinar you’ll be able to: