Regulatory Affairs for Combination Products

Register for this On-demand Training Course training course to learn about FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

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Perspectiva general

Through a series of recorded sessions and interactive online exercises, this On-Demand Training 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.

This on-demand training course takes an average of 8 hours to complete. Learners have access to the course for one year from the date of purchase.

Objetivos de aprendizaje

At the conclusion of this course, participants should be able to:

Compare the similarities and differences in drug and device regulations
Identify opportunities to streamline single entity compliance by integrating drug and device systems
Define risk assessment and management in the combination product environment
Identify the unique requirements of successful combination product development
Define FDA expectations of combination product applicants and how to work successfully with the agency
Determine how human factor considerations are assessed and controlled in the drug/device user interface

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Regulatory Affairs for Combination Products

Perspectiva general

Lo que aprenderá

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Objetivos de aprendizaje

Be informed and stay engaged.