Navigating regulatory change in the US and Europe
Amid unpreceded regulatory disruption, and landmark legislative change, biopharma manufacturers are being subjected to an onslaught of new directions with which to contend. This session will focus on some of the key challenges facing biopharma manufacturers as they strive to remain responsive to regulatory changes, including:
Quality control, and reference standards, in the GLP-1 era
The evolution of GLP-1 drugs from successful diabetes treatments to industry-shaping obesity products has brought with it critical quality control and regulatory compliance challenges. This session will discuss how pharma manufacturers can ensure test methods’ analytical accuracy when identifying and controlling impurities, including:
Lightening the nitrosamine load
Regulatory requirements for nitrosamine impurities are evolving, and the long-running issue continues to present pharma manufacturers with significant risk assessment, confirmatory testing and control strategy implications. As companies contend with the management of nitrosamine drug substance-related impurity (NDSRI) formation across a growing number of products, this session will cover:
