About the Event

The Annual one-day summit will be held in Sydney, Wednesday 22 November 2023. The theme for the summit will be ICH-GCP E6(R3) renovation: Successful implementation through collaboration

The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH-GCP E6(R2) to address the application of GCP across different types of clinical trials and settings, enhance the application of risk-based approaches for clinical trials with a focus on proportionality and quality and facilitate innovations in trial design, technology and digitilisation.

The revised guidelines includes an Annex 1 (IRB/IEC, Investigator, Sponsor and a new section on Data Governance) which consists of four sections including the glossary and three appendices (IB, protocol and amendments and essential records). The principles have been revised to be more flexible and applicable to a broad range of clinical trials. ICH-GCP E6(R3) along with ICH-GCP E8(R1), encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes the evaluation of clinical trial characteristics, such as trial design, the investigational medicinal product being evaluated, participant characteristics, the setting in which the clinical trial is being conducted and the type of data being collected and clinical trial quality.

This summit will be an opportunity to bring all stakeholders (participants, investigational sites, sponsors, service partners and HREC/Governance) across the sector together to share understandings and discuss interpretation and application of E6(R3).

To find out more and to register, visit the ARCS Australia website.

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