2day Inperson seminar on Combination Products How to Get Your Combination Product Approved 2014

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.

Course Agenda/Outline:
Day One
Lecture 1: Introduction To FDA: Laws and Regulations involved
Lecture 2: Definitions
Lecture 3: FDA Office of Combination Products
Lecture 4: What is a Combination Product
Lecture 5: Examples of Combination products
Lecture 6: Mode of Action and Primary mode of Action
Day Two
Lecture 7: Preparation of Request for Designation submission
Lecture 8: User Fees for Combination products
Lecture 9: GMPs for Combination Products
Lecture 10: Frequently Asked Questions about Combination products
Lecture 11: Lead Center
Lecture 12: Post - Approval Modifications

Speaker Profile:
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in