Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations.
This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum of the product lifecycle and who can demonstrate both operational and strategic effectiveness. It covers a variety of key topics including regulatory requirements, submissions, strategy, compliance during pre-market and post-market phases, and addresses requirements in the major international markets.
Participants will learn the fundamentals of regulatory affairs, gain exposure to industry practices, and discover practical applications to develop the interpretive and analytical skills required of a regulatory affairs professional.
This program offers two-tracks: pharmaceuticals (drugs and biologics) or medical devices. With unique products, organizations, regulations, and industry standards, pharmaceuticals and medical devices are often treated as distinct industries. The specialized coursework provides the focused training needed to understand regulatory expectations and how to apply this regulatory knowledge in pharmaceutical and medical device organizations.
Who Should Enroll
This program offers a path for students new to the pharmaceutical and/or medical device industries and to individuals currently employed within these industries who are new to the field of pharmaceutical or medical device regulatory affairs. Additionally, this program benefits current industry professionals with focused regulatory or compliance experience seeking a change in practice setting or job function.