Canadian Packaging

How to get your combination product approved and into the US market

Two-day course helps provide understanding of US FDA combination product system.


May 22, 2014
by Canadian Packaging Staff

A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product—and as one might expect, it is a difficult thing to get into the marketplace.

The Global Compliance Panel is now offering two-day in-person seminars entitled: “Combination Products: How To Get Your Combination Product Approved And Onto The US Marketplace“, a course that has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The 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.

Cost for the event is US $1,295 per attendee, though there is still an early bird option to save $200.

Who will benefit:
Regulatory affairs personnel;
research personnel;
quality personnel;
clinical personnel
manufacturing personnel;
and anyone who requires an understanding of the FDA combination product process.

Location:
July 17-18, 2014
DoubleTree by Hilton Hotel
Philadelphia

August 14-15, 2014
Location TBA
San Francisco

Agenda:
Day 1
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 2
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

The speaker is Albert A. Ghignone, who for over 30 years has focused 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 every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.

To register for this seminar, click HERE.






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