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Webinar: Clinical Quality Management System Optimization

Ensure you are inspection ready during the changing trial landscape imposed by COVID-19 and resultant adjustments in regulations

 

Thursday, April 15, 2021  |  11:00am – 12:00pm EDT

Are you anticipating submitting for market authorization approval and do you know the associated risks? To be compliant with ICH E6 (R2), ICH E8 (R1), and other regulations assessed by auditors and inspectors, risk-based quality management for clinical trials is required. This is even more imperative with the quickly changing trial landscape brought on by COVID-19.

Join this one-hour webinar to evaluate your QMS and ensure you have a solid, risk-based Quality Management System that is compliant with the latest industry regulations during and following the COVID-19 period. We will address the changes required for privacy, quality management, and for validating trials and how to best adapt to overcome the challenges brought on by COVID-19.  These include effective approaches for remote source data review and verification (rSDR/rSDV), use of technology, documenting protocol and ICF deviations or amendments/adjustments, and effective utilization of eTMF to withstand intense regulatory inspections, including newer requirements instituted by ICH E8 (R1) and ICH E6 (R2); even anticipated requirements for ICH E6 (R3).

 

During this webinar, you will:

  • Learn the key components of a QMS to ensure your organization is inspection ready during and after the COVID-19 period.
  • Discuss the implications of ICH E8 (R1), ICH E6 (R2), and the anticipated implications of ICH E6 (R3).
  • Gain insights and ideas for effective implementation processes.
  • Evaluate your QMS framework to ensure it covers all activities, including quality control, quality assurance, quality improvement, and the reporting of these activities within an organization and across partnered companies such as CROs and other providers.
  • Gain access to your complimentary copy of the AQC Quality Agreement Template. This guide is designed to operationalize detailed conversations about quality and oversight expectations between sponsors and providers. Built as a template, it helps users record and track compliance with ICH E6 (R2) and includes a module on inspection readiness (Section 11.2).

 

Presenter:

 

Steve Whittaker

Senior Consultant

The Avoca Group

 


This event is part of Avoca’s 2021 Jon Lee Webinar Series
In tribute to the late Jon Lee, who was an early supporter and one of the first Members of the Avoca Quality Consortium in 2011. Jon was a believer in closing the learning gaps at all levels and often participated in Avoca’s Summits as part of Executive Panels, sharing his experience, and thought leadership. The 2021 quarterly webinar series established in his honor will be focused on sharing knowledge and keeping the clinical trial community connected and informed.