{"title":"Combination Products: How to Get a Product Through The FDA Approval Process","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis 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.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eParticipants 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.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDescribe what combination products are\u003c\/li\u003e\n\u003cli\u003eNavigate the Office of Combination Products\u003c\/li\u003e\n\u003cli\u003eDescribe primary mode of action determination\u003c\/li\u003e\n\u003cli\u003eUnderstand the combination products process\u003c\/li\u003e\n\u003cli\u003eUnderstand Request for Designation submissions\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis course is intended for Regulatory, Clinical, Research, Quality, Manufacturing and other personnel who require an in-depth knowledge of the FDA combination product process.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eAlbert A. Ghignone, M.S., R.A.C.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003e\u003cb\u003eFDA History, Laws, regulations, policies and Guidances\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cb\u003eFDA Definitions\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eWhat are Combination Products:\u003c\/b\u003e Drug\/Biologic; Drug\/Device; Biologic\/Device; Other\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eFDA Office of Combination Products:\u003c\/b\u003e History; Organization; Responsibilities\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eCombination Products Acts, Rules and Regulations:\u003c\/b\u003e Food and Drug Act; 21 CFR  \u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 2: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003ePrimary Mode of Action:\u003c\/b\u003e Definition; Examples\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eRequest for Designation Submission:\u003c\/b\u003e Information in a RFD; Comprehensive review of all RFD sections\u003c\/li\u003e\n\u003cli\u003e\u003cb\u003ePrimary Jurisdiction: CDER; CBER, CDRH\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eGeneral Questions About Combination Products:\u003c\/b\u003e Questions\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eGuidance Douments for Combination Products:\u003c\/b\u003e Guidance Documents\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003eThere will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eReview scenarios and identify solutions\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration 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.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial 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.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett 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.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/combination-products-how-to-get-a-product-through-the-fda-approval-process.oembed","provider":"Barnett International ","version":"1.0","type":"link"}