FDA Regulation of Combination Products webinar at fremont 2017

OVERVIEW:
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.

 

A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Product Id : 501096
Instructor : Thomas E. Colonna

Why Should you Attend:
To gain a fundamental understanding of FDA's regulation of Combination Products.

Areas Covered in the Session:

• Definition of combination product
• FDA Regulatory Pathways
• Primary Mode of Action
• User Fees

Who Will Benefit:

• Regulatory professionals working in the field of combination products
• Compliance Manager
• Validation Manager
• Regulatory Manager
• QC Managers
• QA Managers

IMPORTANT DATE:

Webinar Date: Tuesday, January 24, 2017 | 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Others Details

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