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.
Recent manufacturing advances have led the FDA to proclaim that continuous manufacturing is one of the important tools to modernize the pharma industry through its faster, more efficient processes. The move to continuous manufacturing involves more than just equipment and manufacturing processes. Regulatory compliance must also be considered. Get up to speed on the latest regulatory developments as we look forward to 2020. We’ll discuss key trends and changes in manufacturing that pharma companies should anticipate for a successful year.
Gain insight into global and regional regulatory trends of 2019. Understand which were the most impactful to the industry and reflect on the ramifications for your business.