{"title":"Planning and Conducting Global Clinical Trials","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\"\u003eIncreased competition for clinical trial subjects and resources has spread investigational sites and vendors all over the world. This globalization of clinical trials has helped sponsors to control drug development costs and timelines, but at the same time has generated new challenges for sponsors. This course provides a comprehensive overview of the considerations for planning and conducting trials outside the United States. Expectations of the FDA, EMA, and MHLW for trials conducted outside their regions are reviewed. Strategies for meeting these expectations in the context of differences in clinical research experience, patient populations, medical practice, language, culture, legal and regulatory requirements, logistics, and technological capacity are discussed. The course includes specific operational strategies for clinical trial implementation in both developed and developing countries.class=\"Abstract\"\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\u003eSummarize the trends in globalization of clinical trials\u003c\/li\u003e\n\u003cli\u003eExplain the impetus for globalization of clinical trials\u003c\/li\u003e\n\u003cli\u003eIdentify the factors supporting globalization of clinical trials\u003c\/li\u003e\n\u003cli\u003eUnderstand the impact of the FDA’s, EMA’s, and MHLW’s expectations on global clinical trials\u003c\/li\u003e\n\u003cli\u003eAssess the issues critical to planning a global clinical trial\u003c\/li\u003e\n\u003cli\u003eIdentify key variables for understanding local clinical research environments\u003c\/li\u003e\n\u003cli\u003eRecognize the differences among countries that may be advantageous or challenging to clinical trial sponsors\u003c\/li\u003e\n\u003cli\u003eDevelop capacity for working in a multicultural environment\u003c\/li\u003e\n\u003cli\u003ePredict the challenges involved in global clinical trials\u003c\/li\u003e\n\u003cli\u003eFormulate strategies for meeting the challenges\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\u003eExperienced clinical research professionals who want to develop skills in planning and conducting international clinical trials.\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\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eAnne McDonough, M.P.H., C.C.R.A., M.I.C.R.\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\u003eGlobalization of Clinical Trials:\u003c\/b\u003e Where are clinical trials being conducted? Why are clinical trial sites and services moving around the world?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eFDA Rule on Foreign Clinical Trials\/EMA Reflection Papers\/MHLW Basic Principles on Global Clinical Trials:\u003c\/b\u003e What are the impacts of these documents on the planning and conduct of global clinical\u003cbr\u003e\ntrials?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eConsiderations for Planning Global Trials:\u003c\/b\u003e What are the ethical, scientific, and practical considerations for global clinical trial design and country selection?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eUnderstanding the Local Environments:\u003c\/b\u003e What do we already know? What else do we need to find out? How do we get this information? How can we perform successfully in a multi-cultural environment?\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\u003eclass=\"Abstract\"Regulation:\u003c\/b\u003e How can we ensure compliance with the local clinical trial regulations?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eLegal:\u003c\/b\u003e What other kinds of laws affect clinical trials? How do we manage contracts and insurance?\u003c\/li\u003e\n\u003cli\u003eAbstract\"\u003cb\u003eLanguage:\u003c\/b\u003e What needs translation or interpretation? How do we do it?\u003c\/li\u003e\n\u003cli\u003eAbstract\"\u003cb\u003eCommunication:\u003c\/b\u003e How do we communicate and train in many languages, to people of many cultures, in countries all over the globe, in time zones around the clock?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eLogistics:\u003c\/b\u003e How do we manage international differences in shipping, technology, and currency?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eClinical Trial Procedures:\u003c\/b\u003e What are the considerations for investigational products, study supplies and equipment, informed consent, data collection, monitoring, pharmacovigilance, record retention?\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\u003eBrainstorming group discussions\u003c\/li\u003e\n\u003cli\u003e12 Golden Rules development\u003c\/li\u003e\n\u003cli\u003eSmall group assignments\u003c\/li\u003e\n\u003cli\u003eCross-cultural simulation\u003c\/li\u003e\n\u003cli\u003eChange planning exercise\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# 0778-0000-15-005-L01-P. Released: 4\/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\/planning-and-conducting-global-clinical-trials.oembed","provider":"Barnett International ","version":"1.0","type":"link"}