The Power of Collaboration: AQC Submits Comments to FDA for Consideration to Draft ICH E6(R3)

Posted in Regulatory

WCG’s Avoca Quality Consortium (AQC) provided comments to the FDA as part of the ICH E6(R3) Draft Guidance public consultation on behalf of our 200+ members. By leveraging the power of the consortium, we united cross-functional feedback, representative of all key stakeholders (Sponsors, CROs, Service Providers, and Sites).

The revision to ICH GCP E6(R3) highlights the importance of proportionality and risk-based approaches with focus on quality while encouraging continued innovation; this is a significant update to the conduct of clinical trials for the industry.

In addition to submitting comments on areas that may warrant additional clarity, we have also highlighted training opportunities that may be critical to the successful implementation of this guidance. We anticipate that robust training will strengthen understanding for individual stakeholders as well as ensure consistency across all clinical trial stakeholders.

The Power of Collaboration – thank you to all our members who contributed feedback!

See the comment submission ››

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Published: September 2023