{"title":"Clinical Trials for Medical Devices: Design and Development","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 addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between FDA and sponsors to provide clear direction to support marketing of the medical device.\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\u003eManage the ethical considerations involved in conducting clinical trials\u003c\/li\u003e\n\u003cli\u003eDevelop a strategic plan for successful clinical trials\u003c\/li\u003e\n\u003cli\u003eDevelop trial objectives and hypothesis testing\u003c\/li\u003e\n\u003cli\u003eDevelop protocols in accordance with regulations\u003c\/li\u003e\n\u003cli\u003eEvaluate basic statistical issues relating to sample size\u003c\/li\u003e\n\u003cli\u003eDistinguish and utilize assessment instruments\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\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eStaff from medical device manufacturers or Contract Research Organizations (CROs) who will be involved in the design of clinical trials and have responsibility for protocol development\u003c\/li\u003e\n\u003cli\u003eProject Managers who have little or no clinical trial experience\u003c\/li\u003e\n\u003cli\u003eProject Team Leaders who will be designing clinical trials\u003c\/li\u003e\n\u003cli\u003eClinical, Regulatory, and Development Staff who would like to learn how to design a clinical trial program\u003c\/li\u003e\n\u003cli\u003eInvestigators who would like to learn how to design a clinical trial and about protocol development\u003c\/li\u003e\n\u003c\/ul\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\"\u003eGary B. Freeman, M.S.\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\n\u003cb\u003eHistorical Overview:\u003c\/b\u003e Overview of the regulatory process; general ethical considerations\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eDevice Regulations Pertaining to Device Trial Design and Development:\u003c\/b\u003e “Least Burdensome” approach in the USA; Europe; Japan; “Rest of World”\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eImpact of ICH on Device Trials and Development:\u003c\/b\u003e Principles of ICH GCP E6\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eInvestigational Plan:\u003c\/b\u003e Strategic Planning; Risk Analysis; Clinical Operations; Regulatory Planning: Marketing Considerations\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eTrial Design Considerations:\u003c\/b\u003e Definitions; types; randomizing; blinding or masking; outcomes\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\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\u003eTrial Design Considerations, continued:\u003c\/b\u003e Investigator Selection\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eProtocol Structure and Format:\u003c\/b\u003e Sections and sub-divisions\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003ePopulations:\u003c\/b\u003e Inclusion\/Exclusion Criteria; Cultural Considerations\\\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eDetermining Sample Size; Statistical Power:\u003c\/b\u003e Qualitative and quantitative endpoints, equivalence, rare events; single group\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eObjectives and Hypothesis Testing:\u003c\/b\u003e Null vs. Alternative Hypothesis; Type I and Type II Errors; Single vs. Multiple objectives; statistical concepts for Non-diagnostic devices and diagnostic tests (IVD)\u003c\/li\u003e\n\u003c\/ul\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\u003eEthical Issues\u003c\/li\u003e\n\u003cli\u003eCase Studies: Improving Clinical Trials\u003c\/li\u003e\n\u003cli\u003eControl Groups\u003c\/li\u003e\n\u003cli\u003eGroup Assignments\u003c\/li\u003e\n\u003cli\u003eRationale Evaluation\u003c\/li\u003e\n\u003cli\u003eProtocol Modifications\u003c\/li\u003e\n\u003cli\u003eSample Size\u003c\/li\u003e\n\u003cli\u003eStudy Objectives\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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-003-L01-P. Released: 6\/15.\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\/clinical-trials-for-medical-devices-design-and-development.oembed","provider":"Barnett International ","version":"1.0","type":"link"}