{"title":"Clinical Evidence Writing for Medical Device Regulatory Submissions","description":"\u003cp\u003e\u003cimg title=\"Course Description\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eData used to support regulatory submissions comes from many sources. Clinical evidence can be found in the published literature, company complaints, and in publicly available databases like the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. In this web seminar, we will review how to gather and extract pertinent data from these sources to develop an appropriate analysis for your product and submission. Attendees will learn how to identify quality clinical evidence and utilize it in regulatory submissions.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" style=\"line-height: 1.5em;\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDiscuss the different types of clinical evidence available\u003c\/li\u003e\n\u003cli\u003eIdentify the limitations of clinical evidence\u003c\/li\u003e\n\u003cli\u003eDescribe the content of clinical evidence analysis\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eMedical Writers\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cfont color=\"#800080\"\u003eClick here for complete trainer biographies\u003c\/font\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Registration Fees\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e$695\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIncludes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\" border=\"0\"\u003e\u003cbr\u003e\u003cbr\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-083-L01-P. Released: 8\/15. \u003c\/p\u003e\n\u003cp align=\"center\" class=\"Abstract\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/strong\u003e\u003c\/font\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/clinical-evidence-writing-for-medical-device-regulatory-submissions.oembed","provider":"Barnett International ","version":"1.0","type":"link"}