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.

What You Will Learn
By the end of this session, you will be able to:
  • 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.

Detailed Agenda (180 Minutes)
Block 1:
Block 1:
Introduction – From Paper Protection to Process Protection 

Block 2:
Block 2:
IRB/IEC in E6(R3) - From Approval Stamp to Ethical Partner  
  • Why IRB/IEC interaction matters from a QA perspective.
  • Key changes in responsibilities, independence, and continuous oversight.
Block 3:
Block 3:
Informed Consent - From Signature to Understanding
  • The paradigm shift from document to process.
  • eConsent, comprehension checks, and re-consent triggers.
Block 4:
Block 4:
Practical Scenarios - "Ground Truth" for Ethics 
  • Interactive discussion of real-world cases like "The Hidden Update" and "The Remote Witness."
Block 5:
Block 5:

Live Q&A & Next Steps

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Who Should Attend

  • Regulatory Affairs Professionals
  • CRAs, Monitors, and Clinical Trial Managers
  • Investigators, Sub-Investigators, and Site Staff
  • QA/QC Managers and Auditors
  • Anyone involved in protocol review, IRB/IEC submissions, or the informed consent process.
Featured Speakers
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  • Maxim Bunimovich
    Founder & Director, THE QARP; GCP Auditor and Trainer
    Maxim is an independent international GCP auditor and trainer with over 15 years of experience in the pharmaceutical and clinical industry across Europe, Africa, and CIS regions. A certified MRQA and SQA expert, he combines a medical background with quality management experience. He specializes in GCP audits, FDA & EMA inspection preparation (including mock inspections), and develops Quality Management Systems (QMS) for sponsors and CROs. His practical, audit-based approach forms the foundation of THE QARP's training programmes.
  • Retha Britz
    Senior GCP Auditor & Ethics Expert
    Retha is a highly qualified clinical research consultant and auditor with a deep academic foundation in ethics, holding two Master's degrees in Medical Law & Ethics and Applied Ethics. As the first author of publications and a book on Informed Consent, she brings focused expertise on the webinar's core topic. As the first author of publications and a book on Informed Consent, she brings focused expertise on the webinar's core topic. Her career spans senior international clinical operations and quality assurance management across Africa, the Middle East, and Europe, complemented by extensive experience developing and facilitating accredited training. She has been conducting compliance audits of international clinical trials since 2008.
Registration
This is a complimentary educational webinar. Secure your spot to gain critical insights at no cost.

Group Registration: We encourage teams to attend together. Contact us for assistance with multiple registrations.
FAQ
  • Q:
    Is this webinar really free?
    A:
    Yes, this is a complimentary educational session with no cost to attend.
  • Q:
    Will the webinar be recorded?
    A:
    Yes, a recording will be available to all registered participants after the live event.
  • Q:
    What platform will be used?
    A:
    The webinar will be hosted on Zoom. Login details will be sent before the webinar.
  • Q:
    Can I ask questions during the session?
    A:
    Absolutely! There will be a dedicated live Q&A block.
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