Webinar - Creating a Global CMC Dossier to Achieve Operational Readiness

This webinar presents potential steps to be taken in compiling a truly global CMC dossier. The webinar will discuss how CMC authors and regulatory leaders can best manage the ever-changing regulatory landscape.

The process of developing a new formulation through regulatory approval to achieve operational readiness, is a complicated and multi-dimensional process. The chemistry, manufacturing and controls alone require specialised knowledge and consideration of regional differences. The webinar discusses the key strategies for developing a robust CMC dossier and outlines potential routes to avoid common deficiencies that can lead to a longer regulatory review cycle.

Register for this webinar to learn about the possibilities of harmonising the CMC sections of a global dossier. Learn about potential regulatory reliance strategies for a streamlined approval and how to navigate post approval CMC changes through regional differences.