{"title":"Basics of Post-Marketing Pharmacovigilance and the Beginner PV Auditor","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\"\u003eThe ICH process has resulted in multiple initiatives aimed at harmonizing global regulatory requirements for the approval and marketing of pharmaceuticals.  The EU has faced the additional challenge of harmonizing disparate regulations and practices across multiple cultures and languages. This course will cover the essential ICH pharmacovigilance guidelines for investigational and marketed products, as they have been being implemented in Europe.    The current Volume 9A and Volume 10 nd the implications of the new EU marketed product guidelines will be discussed in detail, including:\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eExpedited and periodic reporting of safety information\n\u003c\/li\u003e\n\u003cli\u003ePharmacovigilance and risk mitigation plans\n\u003c\/li\u003e\n\u003cli\u003eThe role of the Qualified Person for Pharmacovigilance (QPPV)\n\u003c\/li\u003e\n\u003cli\u003eEU PV inspection requirements\n\u003c\/li\u003e\n\u003cli\u003eUse of the EudraCT and Eudravigilance databases\n\u003c\/li\u003e\n\u003cli\u003eSafety data exchange within licensing agreements\n\u003c\/li\u003e\n\u003cli\u003eRepresentation of safety information in the Summary of Product Characteristics\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003eDifferences from US regulatory requirements and additional local requirements will also be discussed. This course will give US pharmacovigilance personnel a working knowledge of exisiting and evolving EU pharmacovigilance requirements and an overview of the processes and procedures needed to ensure compliance with them.\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 style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eReview the regulatory reporting requirements of the EU Clinical Trials Directive (Volume 10) and Volume 9A for companies which develop or market products in Europe\u003c\/li\u003e\n\u003cli\u003eUtilize the tools and mechanisms set up by the EU to enable and assist regulatory compliance\u003c\/li\u003e\n\u003cli\u003eReview the extensive pharmacovigilance inspections now being conducted by Competent Authorities, their findings, and the sanctions that can be imposed upon companies and individuals\u003c\/li\u003e\n\u003cli\u003eRecognize the challenges facing European pharmacovigilance employees of non-EU companies\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 style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eClinical trial safety personnel responsible for multinational clinical trials, as well as safety personnel involved with global post-marketing safety responsibilities\u003c\/li\u003e\n\u003cli\u003ePharmacovigilance personnel involved in auditing of company compliance\u003c\/li\u003e\n\u003cli\u003eSafety personnel responsible for safety data analysis, and for updating safety in the company labels\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\"\u003eSidney N. Kahn, M.D., Ph.D.\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 style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\u003cb\u003eUnderstanding the EU Pharmacovigilance Requirements and Current Interpretation\u003c\/b\u003e\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 style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\u003cb\u003eDeveloping the Processes and Procedures Necessary for Compliance\u003c\/b\u003e\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 style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eShared experiences\u003c\/li\u003e\n\u003cli\u003eGroup discussions\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 Elizabeth Andrews 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# 0778-0000-12-004-L01-P. Released: 4\/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\/basics-of-post-marketing-pharmacovigilance-and-the-beginner-pv-auditor.oembed","provider":"Barnett International ","version":"1.0","type":"link"}