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

June 25, 2018 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

Course Description

Both 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.

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