Webinar on Introduction to FDA Regulation of Combination Products

Event Details

Time: March 31, 2016 from 10am to 11am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Jan 25, 2016

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Event Description

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.

Under 21 CFR 3.2 (e), a combination product is defined to include:

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.

Why should you Attend:

To gain a fundamental understanding of FDA regulation of bioresearch monitoring.

Areas Covered in the Session:

Definition of combination product
FDA Regulatory Pathways
Primary Mode of Action
User Fee

Who Will Benefit:

Regulatory professionals working in the field of combination products

Speaker Profile:

Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.

Contact Detail:

NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Introduction_to_FDA_Regulation_of_Combination_Products