Webinar: Inspection preparation with a risk-based approach consistent with ICH E6 (R2) requirements

Webinar Recorded July 25, 2018

Presented by Steve Whittaker, Senior Consultant, The Avoca Group, and Grace Crawford, VP Clinical Quality and Compliance, MedImmune.

Session discussions:

• Comparison of inspections from different regulatory authorities
• Foci of inspectors
• First-hand experiences of sponsors to uncover common pitfalls
• MHRA’s emphasis on conducting a risk-based analysis
• Compliance with ICH E6 (R2) changes by adapting risk-based tools and methods
• Effect a risk-based approach to inspection readiness with tried and tested strategies

The Avoca Group’s consulting services are grounded in the leading practices and tools from the Avoca Quality Consortium® and customized to drive measurable improvements to quality and compliance in the execution of clinical trials. To learn more, or to speak with a representative, contact us.