Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Medical Device GCP Overview
Upcoming Courses
This course provides information across the full range of medical device clinical trial activities; and applicable Good Clinical Practices (FDA 21 CFR 812 Investigational Device Exemption, ISO 14155 Clinical Investigations of Medical Devices, and principles of ICH Good Clinical Practices E6 Guideline). It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.
- Recognize the regulatory pathways for medical devices in the U.S
- Explore practical aspects of investigator and monitor selection
- Discuss how to comply with the fundamentals of Good Clinical Practice (GCP)
- Examine practical aspects of conducting international clinical trials
- Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
- Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials
- Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process
- Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process
Gary B. Freeman, M.S.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Medical Device and Good Clinical Practices
- Medical Device and Regulatory Requirements
- Clinical Research Team: Role and Responsibilities
Day 2: 8:30 a.m. – 5:00 p.m.
- Clinical Study Protocol Elements and Device Accountability
- Role of Institutional Review Board (IRB) and Informed Consent
- Principles of Ethics and Quality Control
- Clinical and Data Management Discussions
- Review of Regulatory Documents
Registration 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.
Special 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.
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Barnett 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# 0778-0000-16-035-L01-P. Released: 12/16.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
