This free, live webinar moves beyond the text of ICH GCP E6(R3) to explore its profound impact on the ethical pillars of clinical research. Join Senior GCP Auditors Retha Britz and Maxim Bunimovich as they decode how R3 reframes IRB/IEC responsibilities and transforms informed consent into an ongoing, participant-centric process. Learn practical strategies to implement these changes and protect your trials from ethical and compliance pitfalls.
Explain how E6(R3) reframes ethics, participant protection, and oversight.
Identify what IRBs/IECs are now expected to review and document.
Design an informed consent process (including eConsent) that meets new expectations.
Recognize and handle common ethical pitfalls in a way that withstands audit scrutiny.
Live Q&A & Next Steps
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