{"title":"Placebo Trials for Medical Devices: FDA’s Steps to Ensure Reliability of Medical Devices","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eAs of 2014, device companies must consider the placebo effect in clinical trials and how placebo controls will affect their regulatory approval pathway. Randomized, placebo controlled trials are not new to those in the pharmaceutical industry, but they have not traditionally been the norm for device trials. Approval in the EU does not assure approval in the U.S. Will Congress be asked “to ensure that all devices provided to patients be safe and effective” rather than “reasonably” safe and effective? What are the ethical considerations? How will this issue affect conducting medical device clinical trials in the U.S. and abroad? Sponsors should be prepared to discuss and defend their position on the necessity of a placebo controlled trial. This web seminar will provide strategies for adapting to this changing regulatory landscape. The course instructor, a former FDA insider, will share case studies to help sponsors and investigators better prepare for unanticipated FDA questions.\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\/Web_Seminars\/LearningObjectives.jpg?n=4499\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDetermine if and when it may be necessary for placebo trials\u003c\/li\u003e\n\u003cli\u003eInterpret FDA’s current thinking on clinical trials to ensure reliability of medical devices\u003c\/li\u003e\n\u003cli\u003eOptimize time with the FDA to facilitate and capture what sponsors need to fulfill regulatory requirements\u003c\/li\u003e\n\u003cli\u003eConsider the ethical ramifications on placebo controlled studies\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\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eSponsors\u003c\/li\u003e\n\u003cli\u003eClinical Research Professionals\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eInvestigators and Site Staff\u003c\/li\u003e\n\u003cli\u003eIRB Professionals\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eAuditors\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\/Web_Seminars\/Instructor.jpg?n=9798\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cspan class=\"Abstract\"\u003eJerri Barden Perkins, M.D.\u003c\/span\u003e \u003c\/p\u003e\n\u003cp\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\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\"\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 1-800-856-2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\"\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 mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-15-021-L01-P. Released: 2\/15. \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"center\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/strong\u003e\u003c\/font\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"left\"\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"left\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/placebo-trials-for-medical-devices-fdas-steps-to-ensure-reliability-of-medical-devices.oembed","provider":"Barnett International ","version":"1.0","type":"link"}