How to Get Your Combination Product Approved and onto the US Marketplace Seminar 2014
conferences > Health conferences > How to Get Your Combination Product Approved and onto the US Marketplace Seminar
August 14 - 15, 2014
This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Why should you attend?
A must course for those who have Combination Products or are anticipating that they will have Combination Products. This course explains the entire FDA Combination Product system and how to navigate the FDA Combination Product system. If your concern is getting your Combination Product on the US marketplace this course is a must attend for you.
ABOUT SPEAKER –
Albert A. Ghignone
Chief Executive Officer and President, AAG Incorporated.
Location: San Francisco Date: August 14th & 15th 2014 Time: 9 AM to 6 PM PDT
Price: $1,295.00
Discount:
Register now and save $200. (Early Bird)
Until June 20, Early Bird Price: $1,295.00
from June 21 to August 12, Regular Price: $1,495.00
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.
Why should you attend?
A must course for those who have Combination Products or are anticipating that they will have Combination Products. This course explains the entire FDA Combination Product system and how to navigate the FDA Combination Product system. If your concern is getting your Combination Product on the US marketplace this course is a must attend for you.
ABOUT SPEAKER –
Albert A. Ghignone
Chief Executive Officer and President, AAG Incorporated.
Location: San Francisco Date: August 14th & 15th 2014 Time: 9 AM to 6 PM PDT
Price: $1,295.00
Discount:
Register now and save $200. (Early Bird)
Until June 20, Early Bird Price: $1,295.00
from June 21 to August 12, Regular Price: $1,495.00
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How to Get Your Combination Product Approved and onto the US Marketplace Seminar August 14 - 15, 2014
