Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

This 60-minute webinar is designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance. The speaker breaks down the key shifts, themes, and differences between R2 and R3, provides real-world examples to simplify the changes, and introduces a framework to help identify gaps and prioritize the next steps for compliance.

How Do IRBs Review Virtual Trial Technology?

How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.

Building Clinical Trial Diversity Action Plans for the Future, Now

Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.