This course provides a comprehensive approach to the preparation and submission of FDA documents for approval of combination products. Participants receive a foundation of knowledge about the combination product process, submission preparation and the underlying scientific and regulatory principles involved.
Participants will gain knowledge about the FDA Office of Combination Products, the combination product process, request for designation submission, primary mode of action determination and the entire combination product system.
- Describe what combination products are
- Navigate the Office of Combination Products
- Describe primary mode of action determination
- Understand the combination products process
- Understand Request for Designation submissions
This course is intended for Regulatory, Clinical, Research, Quality, Manufacturing and other personnel who require an in-depth knowledge of the FDA combination product process.
Albert A. Ghignone, M.S., R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- FDA History, Laws, regulations, policies and Guidances
- FDA Definitions
- What are Combination Products: Drug/Biologic; Drug/Device; Biologic/Device; Other
- FDA Office of Combination Products: History; Organization; Responsibilities
- Combination Products Acts, Rules and Regulations: Food and Drug Act; 21 CFR
Day 2: 8:30 a.m. – 5:00 p.m.
- Primary Mode of Action: Definition; Examples
- Request for Designation Submission: Information in a RFD; Comprehensive review of all RFD sections
- Primary Jurisdiction: CDER; CBER, CDRH
- General Questions About Combination Products: Questions
- Guidance Douments for Combination Products: Guidance Documents
There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- Review scenarios and identify solutions
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-087-L01-P. Released: 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.