Live Webinar Risk Mitigation Changes with ICH E6(R3) and E8(R1) August 25th

8/18/2020

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Topic: Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

When: August 25, 2020

Time: 1:00 p.m. – 2:00 p.m. EDT

Register: Here

Description: Change is coming again. Expected updates to ICH GCP E6(R2) and ICH E8 support the agility and adaptability we need to reach the levels of study design, management, and conduct closest to the data and subjects. Taking these theoretical concepts into flexible, reliable, and accountable practices is the next step in more effective trials.

Join Sandra “SAM” Sather as she presents some insights for proactive preparation for the upcoming changes. Understand the biggest internal barriers related to mindset and quality systems, which are key points of the revisions. As many stakeholders did not prepare for change before ICH E6(R2), it created a challenging and costly process to assimilate meaningful change. Therefore, preparing a foundation for these changes is essential.

Learn more about:

  • What is likely to change from ICH GCP E6(R2)

  • Why ICH E8 is also changing

  • What are some additional themes and reasons for change that you should know (i.e., “critical-to-quality factors” and related gaps in critical thinking)

  • Steps you can take as a site, sponsor, or CRO to assess gaps in essential mindsets, skill sets, and systems to prepare for these changes

- The Clinical Pathways Team

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