Menu Back to Ethical-Review-Boards

Overview

A UL EduNeering course

This course covers the roles, responsibilities, and regulatory requirements of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) in protecting the rights and welfare of human research subjects. This course reviews regulations, guidelines, International Conference on Harmonisation (ICH) good clinical practice (GCP), and the EU directive.

Learners will gain insight into the relationship between the IRB and IEC and how to sponsor or monitor the investigators or subjects involved.

Featured topics

  • Roles, responsibilities, and regulatory requirements of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs)
  • Development of ethical review systems
  • Membership/procedures
  • Review and approval
  • Responsibilities
  • Vulnerable subjects
  • Noncompliance
  • Compliance resources

Who should attend?

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Contact us