Are the Intended Benefits of ICH Regulations Obscured by the Adoption Struggle?

August 25, 2020

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ICH E6(R3) is coming at a time when organizations are struggling to adopt ICH E6(R2). Fundamental to these new guidelines is the modernization of processes and technology (e.g., machine learning) to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices. Live: Tuesday, Aug. 25, 2020 1pm EDT | 12pm CDT | 10am PDT On demand available after airing until Aug. 25, 2021. Register free

Register free: http://www.appliedclinicaltrialsonline.com/act_w/benefits_ICH

Event Overview
ICH E6(R3) is coming at a time when organizations are struggling to adopt ICH E6(R2). But should organizations wait until these guidelines are ratified to realize the intended benefits? Being proactive is diametrically opposed to the industry norm ‘wait and see’ approach, which may result in regulatory findings (e.g., 483 letters) and incur unnecessary change costs.

Fundamental to these new guidelines is the modernization of processes and technology (e.g., machine learning) to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices.

Emphasis on quality is everywhere, but study startup is a hotspot, as it is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages which can derail a study resulting in costly rescue interventions, often due to issues that are preventable.

But what are the benefits from implementing ICH regulations now? And is change management the greatest challenge to overcome in the adoption struggle?

Key Learning Objectives:

In this webcast we will explore:

  • The intended purpose of ICH regulations to implement industry best-practices and not to add additional burdens on clinical research staff

  • How to realize proactive gains vs. incurred costs/compliance issues by adopting ICH regulations

  • How by implementing QbD and risk-based management processes operational efficiencies can be gained by minimizing retrospective duplicate quality assurance steps

  • How to enhance quality by minimizing protocol deviations/amendments by focusing on study design and startup

  • Strategies to overcome adoption struggles and celebrate quick wins

SpeakersAndy Lawton, Consultant, Risk Based Approach Ltd

Crissy MacDonald, Executive Director, Client Delivery, The Avoca Group

Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Time and date: Tuesday, Aug. 25, 2020 1pm EDT | 12pm CDT | 10am PDT

On demand available after airing until Aug. 25, 2021.

Sponsor: Oracle Health Sciences

Register free: http://www.appliedclinicaltrialsonline.com/act_w/benefits_ICH

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