Employing Comprehensive Product Lifecycle Management Strategies such as Continued Monitoring of ICH Standards and Regulatory Requirements through to Stringent Supply Chain Change Control Processes to Ensure Compliant Pre-Market and Postmarket CMC Operations
Regulatory affairs chemistry, manufacturing and control operations are a critical component for the success development, approval, manufacturing, and marketing of consistently highly effective and safe therapies. As products continually become more complex in not only product design but in the compound and chemical makeup, CMC executives are challenged with obtaining the high levels of evidentiary support to showcase the product’s overall performance and quality. Building on conference knowledge share and success of this annual conference, the 2018 program will showcase industry experts within CMC operations, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a range of topics from highlighting CMC data requirements and regulations from different global marketplaces, streamlined approaches to combination product CMC and best practices for conducting CMC operations for expedited pathway approvals.