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Event Manager
NetZealous - Compliance4All
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Event 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;
  • Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug 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

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/1LLEDvl

Contact the event managers listed below for more information about how you can participate at the Webinar on FDA Regulation of Combination Products.

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Event Details

Website: http://bit.ly/1LLEDvl...
Conference/Event Dates: 11/19/2015 - 11/19/2015
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Clinical Pharmacology, Professional Healthcare, Sciences
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: Regulatory professionals working in the field of combination products

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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Webinar on FDA Regulation of Combination Products

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