Key Update On Guideline For Good Clinical Practice E6(R3)

By Elizabeth Bodi

Key components of the updated ICH GCP guidelines, specifically the E6 (R3) Principles and Annex 1, have been formally adopted by the ICH Assembly, signaling an advancement from the R2 standards. These guidelines are now moving forward toward acceptance by global health authorities. E6 (R3) aligns with key concepts from ICH E8(R1) and is designed to foster a stronger culture of quality in clinical trials and overall drug development. Review the details on these changes, as well as what preparations and next steps your organization needs to undertake in light of this adoption.