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Summary of the workshop:
This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.
Participants will learn what a Combination Product is, learn about mode of action and primary mode of action, how to prepare a Request for Designation submission, Combination Product user fees, GMP for Combination Products and how to interact with the FDA Office of Combination products. They will also learn about submissions for post-approval modifications for a Combination product. This course provides the participant the ability to understand the entire FDA Combination Product Process and how to navigate through the FDA Combination Product Process to get your Combination Product onto the US marketplace.
Learning Objectives from this Workshop:
Learn about the FDA Office of Combination products
Learn what a Combination Product is
Learn the FDA Combination Product Process
How to navigate the FDA Combination Product system
Mode of action and primary mode of action
How to prepare a Request for Designation
User Fees for Combination products
GMPs for Combination products
RAC Credits: 12
Regulatory Affairs Personnel, Research Personnel, Quality Personnel, Clinical Personnel, Manufacturing Personnel, Personnel who require an understanding of the FDA Combination Product Process.
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