LIVE VIRTUAL WORKSHOP
ICH E6 (R3) Good Clinical Practice and Regulatory Requirements
Why this workshop matters
The latest version of the Good Clinical Practice guideline – ICH E6 (R3) – brings a shift in how clinical trials are designed, monitored and managed. With increasing regulatory expectations around risk-based quality management, new roles and relationships, and digital-enabled trial conduct, you need clarity, alignment and practical tools to stay compliant and efficient.
This ICH E6 (R3) training session meets the minimum criteria by TransCelerate BioPharma as necessary for mutual recognition of GCP training for trial sites.
You can claim 4 CPD points from this workshop and you will receive an ICH E6 (R3) certificate.
What will you learn?
On completion, you will be able to:
- Gain a clear, applied understanding of what ICH E6 (R3) updates mean for your organisation.
- Review how key stakeholders (sponsors, CROs, sites, investigators, monitors) will need to adjust how they work.
- Explore how to implement the updated GCP framework into your SOPs, site processes, monitoring approach and governance model in a way that is clear, actionable and audit-ready.
Who is this workshop for?
This workshop is designed for professionals who need to lead or support the transition to ICH E6 (R3)-aligned ways of working, including:
- Clinical trial managers & coordinators
- QA, regulatory & compliance specialists
- Site-based research or clinical operations staff
- Sponsor and CRO responsible for trial oversight
What participants will get
By the end of the workshop, you will:
Understand the key changes introduced in ICH E6 (R3) and why they matter
Understand how ICH E6 (R3) impacts trial sites, sponsors and CROs
Gain insights to support the move to a risk-based framework
Understand the evolving roles of sponsors, CROs, site staff, investigators and monitors
Identify where existing SOPs and processes may need to be updated to align with the new Guideline
Understand how sponsor monitoring approaches are likely to change
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
Thursday 21 May 2026: 10.00am – 2.00pm (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.
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