Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Course Description

Both the ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Learning Objectives

• Discuss the purpose and governing bodies of ICH and ISO
• Explore the core principles of each document
• Describe similarities and key differences in content and approach
• Identify additional sources of information relating to the compliant conduct and oversight of medical device studies

Who Should Attend

• Project Managers
• Clinical Research Associate Managers
• Clinical Research Associates
• Clinical Investigators
• Study Coordinators
• Clinical Quality Assurance Professionals
• Institutional Review Board Professionals

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Registration Fees

$735

Includes 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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett 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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-057-L99-P. Released: 8/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.