The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators.

Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the ...

The FDA has adopted the updated ICH E6 (R3) Good Clinical Practice guidelines, marking the biggest overhaul in decades. The new framework emphasizes risk-based, quality-by-design approaches, stronger ...

This workshop investigates the meaning of Good Clinical Practice (GCP), where it is applicable, and how it differs from other regulations governing clinical research. The focus is on aspects of GCP ...

TransCelerate BioPharma has released a summary report from a joint tabletop exercise conducted with the FDA's Center for Drug ...

The FDA has finalized guidance on decentralized clinical trials (DCTs) as AI and data science tools gain traction in drug development. The updated ICH E6(R3) Good Clinical Practice guideline ...

The Sports Authority of India (SAI), in collaboration with the Indian Council of Medical Research (ICMR), conducted a workshop on Good Clinical Practice (GCP) to strengthen ethical sports science ...

Visit NAP.edu/10766 to get more information about this book, to buy it in print, or to download it as a free PDF. Clinicians can no longer stay abreast of the rapidly expanding knowledge bases related ...