ICH E6(R3) Sponsor Responsibilities Training
NEW: Sponsor Responsibilities ICH E6 (R3) GCP Workshop
“ICH E6(R3) places greater demands on sponsor oversight, quality and risk management. Sponsors will gain the practical knowledge to meet sponsor responsibilities with confidence.” – Dr Tanya Symons, Recognised GCP Expert and PRAXIS Workshop Facilitator
The ICH E6 (R3) Good Clinical Practice Guideline is the global standard for the ethical and quality conduct of clinical trials involving medicines and biologicals. The updated guideline introduces stronger expectations for risk-based quality management, digital trial delivery, data governance and sponsor oversight.
This practical workshop supports sponsor personnel and those overseeing sponsor responsibilities in non-commercial and investigator-led trials.
Workshop Overview
Sponsors may delegate activities to coordinating principal investigators, clinical trial units, CROs, trial teams and third parties, but they remain accountable for participant safety, trial quality and regulatory compliance.
This workshop explores how to maintain effective oversight when responsibilities are distributed across multiple people and organisations, and how to apply ICH E6 (R3) requirements in practice to protect participants, ensure data integrity and support compliant trial delivery.
Who Should Attend?
- CPIs delegated sponsor responsibilities in collaborative group or investigator-led trials
- Trial team staff delegated sponsor responsibilities
- Governance staff responsible for trial oversight
- Others seeking to learn about sponsor responsibilities in non-commercial trials
What You Will Learn
By the end of this session, participants will be able to:
- Recognise and apply the core principles of ICH E6 (R3)
- Understand the key responsibilities of the trial sponsor
- Apply Quality-by-Design principles to strengthen scientific and operational integrity
- Recognise the key approaches to trial monitoring and understand their relative strengths and limitations
- Understand the key expectations for data governance
- Identify and prevent common sponsor audit and inspection findings
CPD points: Participants can claim 4 CPD points for completing this workshop.
Workshop Format
This four-hour live virtual workshop combines expert instruction with practical activities, discussion and opportunities to ask questions.
Other ICH E6 (R3) GCP Training
Prefer a broader ICH E6 (R3) Workshops that focuses more on investigator and site team responsibilities? See our: ICH E6 (R3) Good Clinical Practice and Regulatory Requirements Workshop
This workshop can also be delivered as a tailored offer for organisations and groups of ten or more participants.
Our training and education offers have been developed according to Australian and international best practice standards.
Our modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
About the Facilitator
Dr. Tanya Symons
Dr. Tanya Symons is a highly experienced clinical trial trainer and consultant, both in Australia and internationally. She has delivered GCP, clinical trial and ethics training to over 90,000 people.
In 2012, Tanya redeveloped and continues to write the content for the UK’s NIHR Clinical Trials Toolkit. In Australia, she works with governments, government-funded organisations and trial sponsors to ensure that trial initiatives align with international best practices. She has authored or co-authored several national guidelines, including the TGA Australian Clinical Trials Handbook, the NHMRC Safety Reporting and Serious Breach Guidelines and the ACTA/CTIQ Consumer Involvement and Engagement Toolkit. Tanya also led a joint ACTA/ARCs project to provide national feedback on the draft ICH E6 R3 Guidelines.
Price
Price: $599 +GST pp
PRAXIS Partner price: $479 +GST pp
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
TBC: 10.00am – 1.00pm (Sydney Time)
Need training on demand?
This session can also be conducted at your location for groups of 10 or more. Ask us about this today.
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.