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Webinar on Introduction to FDA Regulation of Combination Products

Webinar on Introduction to FDA Regulation of Combination Products

Views: 723

03/31/2016 - 03/31/2016

Webinar

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Event Contacts


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

Event Description

Overview: 

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;
  • A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
  • Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

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

Not sure if you want to exhibit at or attend the Webinar on Introduction to FDA Regulation of Combination Products? See the panels below to get the information you need to make an informed decision.

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Event Details

Website: http://www.compliance4all.com/...
Conference/Event Dates: 03/31/2016 - 03/31/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: http://bit.ly/Introduction_to_FDA_Regulation_of_Combination_Products...
Audience: Regulatory professionals working in the field of combination products
Show Owner:NetZealous - Compliance4All

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 Introduction to FDA Regulation of Combination Products

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