概要
This introductory course will provide learners with an overview of FDA’s approach to regulation of combination products including review of FDA’s recent guidance. Topics will cover processes to streamline and integrate development of single entity, co-packaged and cross-labeled products. Discussion will cover approaches to aligning requirements between drugs and devices and assuring successful human factors interface. Course material will address FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications. Workshops will offer practical applications in when and how to report as a constituent product or as a combination.
Travel once and double your learning by attending two of DIA's regulatory affairs courses back-to-back in Washington, DC! Register now for Regulatory Affairs for Combination Products and Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process training courses today.
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