Preparing for ICH E6 (R3) Good Clinical Practice Changes

Abstract

Our industry is eager to learn what changes are included in ICH E6 (R3) Good Clinical Practice recommendations this year. Understanding how taking a risk-based, fit-for-purpose approach in the use of technology to conduct clinical trials will impact the industry’s current procedures. A key focus includes Quality Tolerance Limits (QTLs) and how clinical trial teams can identify, manage, and report risks associated with critical to quality factors that answer key questions and support sound decision-making while protecting patients. The focus of this webinar is how sponsors, CROs and sites can focus on quality factors at the time of trial design and prepare for these new rules.

Josh Rochotte

Ph.D. Student in Information Science

Behavioral Informaticist - AI/ML Product Manager - Therapeutic Game Master - Certified Nerd - Infinitely Curious