Chemistry, Manufacturing and Controls (CMC or Quality) is one of the
three key areas (with Safety and Efficacy) that health authorities
(HAs) consider for the review and approval of drug applications.
Effective CMC strategies and execution may reduce regulatory burden,
enable shorter review timelines, and support postapproval maintenance.
This program will convey key CMC concepts, challenges and opportunities
encountered by those working in regulatory strategy as well as those in
functional areas who partner with regulatory to achieve business goals.
In addition to demonstrating technical proficiency related to CMC,
regulatory professionals must also cultivate strong partnerships with
internal and external functional areas in order to achieve their
strategic and tactical goals. These partnering functional areas,
including business development, operations, product development and
product lifecycle management, play an integral role in product
development. Regulatory’s ability to understand how these functional
areas’ activities interact with and support CMC can have a considerable
impact on an organization’s ability to successfully launch a new drug.
Primary areas of focus for this program include (1) knowledge and
execution, (2) enabling business objectives and (3) pressing technical
issues. Hot topics will be addressed by experts in the field to provide
critical details and key take-aways. Both days will provide
participants with opportunities to query the speakers, share
experiences to promote mutual development, and engage with new
colleagues for professional growth.