{"title":"18-Hour Writing Clinical\/Performance Evaluation Reports","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eElevate your regulatory expertise and gain a competitive edge in the\nmedical device industry with our comprehensive course on Clinical and\nPerformance Evaluation Reports for markets outside the US. This course\nexamines Clinical\/Performance Evaluation Reports (CER\/PER) requirements\nfor EU MDR and IVDR (EU Reg 2017\/745 and 746, respectively) and\nassociated guidelines. The course curriculum also includes a peek at CER\/\nPER regulations outside the US. International and EU markets mandate\nthe requirement to have a CER\/PER for all medical device products.\nThis program focuses on helping learners master effective evaluation\nand writing skills with techniques provided to ensure good CER\/PER\ndevelopment and a clear understanding of potential reviewer comments\nwith strategies to address Notified Body deficiencies if any have been\nnoted in the past. This course will include interactive sessions, encourage\nparticipant experience sharing and will address specific CER\/PER inquiries.\n\u003c\/p\u003e\u003cp\u003e\u003cb\u003eTextbook Included! \u003c\/b\u003e\u003ci\u003ePlanning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs\/PERs)\n        A Practical Guide for the European Union and Other Countries\u003c\/i\u003e\n\u003c\/p\u003e\u003cp\u003ePrior to the start of the course, participants will receive their login\n    credentials and links to access and download the many class resources\n    and class meeting links. Upon course completion, participants will be\n    provided training certificates. In order to receive accreditation CEUs,\n    participants are required to pass both a mid-term and final exam. Upon\n    completion of the exams, CEU certificates will be provided.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eAnalyze CER\/PER development and evolution as the device matures\u003c\/li\u003e\n\u003cli\u003eInterpret EU MDR (EU Reg 2017\/745 and 746) CER\/PER requirements and associated guidelines\u003c\/li\u003e\n\u003cli\u003eConstruct CER\/PER development work plans\u003c\/li\u003e\n\u003cli\u003eIdentify critical CER\/PER elements for Notified Body evaluation\u003c\/li\u003e\n\u003cli\u003eApply CEP\/PEP template (provided) for plan completion\u003c\/li\u003e\n\u003cli\u003eUse CER\/PER template (provided) for report completion\u003c\/li\u003e\n\u003cli\u003eImplement PMCFP\/PMPFP template (provided) for plan completion\u003c\/li\u003e\n\u003cli\u003eFormulate responses to expert CER\/PER reviewer critiques to learn more\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eModule 1: Introduction and CER\/PER Requirements\u003c\/li\u003e\n\u003cli\u003eModule 2: Planning Clinical\/Performance Evaluations\u003c\/li\u003e\n\u003cli\u003eModule 3: Identifying Clinical\/Performance Data\u003c\/li\u003e\n\u003cli\u003eModule 4: Appraising Clinical\/Performance Data\u003c\/li\u003e\n\u003cli\u003eModule 5: Analyzing Clinical\/Performance Data\u003c\/li\u003e\n\u003cli\u003eModule 6: Establishing Clinical Benefit-Risk Ratios\u003c\/li\u003e\n\u003cli\u003eModule 7: Writing Clinical\/Performance Evaluation Documents\u003c\/li\u003e\n\u003cli\u003eModule 8: Writing SSCPs\/SSPs \u003c\/li\u003e\n\u003cli\u003eModule 9: Reviewing CE\/PE Documents\u003c\/li\u003e\n\u003cli\u003eModule 10: Integrating CE\/PE, PMS and RM Systems\u003c\/li\u003e\n\u003cli\u003eModule 11: Understanding CER\/PER Regulations Outside of Europe\u003c\/li\u003e\n\u003cli\u003eModule 12: Forecasting CER\/PER Future Directions\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cb\u003eAvailable by individual module! Contact Barnett to learn more.\u003c\/b\u003e\n\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eClinical Data Specialists\/Analysts\/Managers\u003c\/li\u003e\n\u003cli\u003eTechnical Communication Specialists\/Medical Writers\u003c\/li\u003e\n\u003cli\u003eClinical Affairs Directors\u003c\/li\u003e\n\u003cli\u003eClinical Program Managers\/ Clinical Nurse Specialists\u003c\/li\u003e\n\u003cli\u003ePost Market Surveillance Managers\u003c\/li\u003e\n\u003cli\u003eClinical Evaluation Report\/Reporting Specialists\u003c\/li\u003e\n\u003cli\u003eEvaluation and Research Directors\u003c\/li\u003e\n\u003cli\u003eClinical Education Specialists\u003c\/li\u003e\n\u003cli\u003eCorporate Librarians\u003c\/li\u003e\n\u003cli\u003eRegulatory Specialists\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/b\u003e\n\u003c\/p\u003e\u003cp\u003e“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S, F.R.A.C.P\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\n            biographies\u003c\/a\u003e\n\n \u003c\/span\u003e\n\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse\n Length and Time\u003c\/i\u003e\n \u003c\/b\u003e\n \u003c\/span\u003e\n\u003c\/p\u003e\u003cp\u003e1.5 hours\/week for 12 weeks.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,795 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,995 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 18 hours (1.8 CEUs) of continuing education credit for full participation, including\n    the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-064-L99-P. Released: 9\/24.\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n        215.413.2471.\u003c\/span\u003e\n\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/18-hour-writing-clinical-performance-evaluation-reports.oembed","provider":"Barnett International ","version":"1.0","type":"link"}