Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5138944 | Microchemical Journal | 2018 | 10 Pages |
Abstract
Among the several new provisions foreseen by the EU Regulation (R) 2014/536 on Clinical Trials (CTs) repealing Directive (D) 2001/20/EC, this article focuses on the identification of possible critical points leading to potential incongruences regarding Good Clinical Practice (GCP). EU D foresees the obligation to be in compliance with GCP detailed guidelines, while the R foresees the obligation to be in compliance only with the GCP principles. Many of the GCP detailed aspects have been transposed in the R and the R provides to be in compliance with GCP quality standards. Nevertheless, other GCP aspects, which have direct or indirect ethical implication in CTs, will not be mandatory in the EU.
Keywords
Related Topics
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Analytical Chemistry
Authors
Umberto Filibeck, Eleonora Sanzi,