PTI - international

Course Description

Chemistry, Manufacturing and Controls (CMC) is a critical drug approval issue for FDA. The CMC data section comprises one third of a new drug application and firms can only receive product approval if this data is accepted by the agency. The FDA's CMC pipeline is constantly evolving, and industry is facing new expectations and requirements. It is vital for drug companies to keep abreast of this rapidly evolving regulation because non-compliance with FDA requirements can cause significant delays in obtaining product approval which costs a firm valuable time and money. This training program provides a comprehensive overview of the FDA's CMC requirements. The course begins with a brief introduction and review of FDA CMC regulatory developments. Discussions of FDA/sponsor meetings will help participants learn how to most effectively communicate CMC submission information to agency reviewers in the earliest stages of drug development. Unique CMC regional requirements will be explored and best strategies outlined on how to create a core international dossier. By the end of this two-day interactive course, participants will be well-versed on how to report post-approval manufacturing changes, the importance of drug master files, and how to best utilize comparability protocols. Throughout the duration of the course, attendees will be given the chance to participate in interactive exercises and discussions designed to ensure that classroom learning transfers to on-the-job improvement!