Regulatory tactics consist of managing the specific elements required for premarket submissions in the U.S. or elsewhere. A global regulatory strategy, on the other hand, is a much broader, more comprehensive assessment of the world’s regulatory and market potential landscape, and the development of a master plan aligned with a company’s ultimate business objectives.
A regulatory strategy involves both the evaluation and coordination of internal resources and an understanding of a dramatically changing global environment. Where are the preferred markets to achieve the company’s short- and long-term aims? What evidence or approvals from one region can be leveraged to facilitate access to another?
This unique, highly interactive workshop brings together senior regulatory leaders from the medical device industry with extensive experience in global regulatory strategy to share knowledge and best practices.
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