Course description
With the current regulatory fragmentation and changing requirements, successful generic companies need to understand how to overcome the issues especially around CMC documentation, operational inefficiencies and grey zones in generic applications.
Generics face specific CMC challenges and continue to experience a
significant number of deficiencies in CMC section, which is resulting in
the long review cycles, amendment cycles and delayed decisions from
the regulatory authorities.
This 2-day practical course was designed to equip regulatory, CMC, and quality professionals with the advanced skills and knowledge needed to navigate the evolving landscape of generics applications.
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