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

Tuesday, August 25, 2020  |  1:00pm – 2:00pm EDT

 

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?

 

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

 

This webcast is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for collecting and evaluating trial metrics
  • Sponsor and CRO roles responsible for project management of studies and operational excellence

 

Speakers:

Andy Lawton

Consultant

Risk Based Approach Ltd

 

Crissy MacDonald

Executive Director, Client Delivery

The Avoca Group

 

Elvin Thalund

Director, Industry Strategy

Oracle Health Sciences