Name
ICH E6(R3) Countdown: Insights on Readiness, Risk, and Collaboration 
Date & Time
Wednesday, October 23, 2024, 1:00 PM - 2:00 PM
Track
Quality / Regulatory
Description

Join us as we discuss the latest findings from the Avoca Industry Survey Report on the industry's awareness, anticipated impact, and preparedness for the upcoming release of ICH E6(R3) expected by the end of 2024. This session will provide insights into who may face the steepest learning curve (spoiler alert - it's sites), the potential impact of R3 on trial conduct, and steps organizations are taking to prepare. We'll also explore industry perceptions on key areas of the guidance, including the importance of risk-proportionate approaches, the potential for increased site burden, and ways sponsors can mitigate these concerns.

Attendees can expect to gain a better understanding of the industry's current state of readiness and the critical factors to consider when implementing ICH E6(R3). We will also discuss the opportunities for collaboration across stakeholders in the clinical trial ecosystem and how early engagement can facilitate successful implementation.

Key takeaways will include:

  • Insights into the industry's awareness and preparedness for ICH E6(R3)
  • Idntifying of the potential impact on trial conduct and site burden
  • Strategies for implementing risk-proportionate approaches and mitigating site burden concerns
  • The importance of collaboration and early engagement in successful ICH E6(R3) implementation

Don't miss this opportunity to engage and gain valuable insights on this important topic.

Karen Harvey Michelle Webb