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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
ICH E6(R2): Good clinical practice [1] is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. [2]
In 2025, the works unbound from copyright cap off the 1920s with literature, characters and more from 1929 entering the public domain.
Site Reliability Engineering (SRE) is a discipline in the field of Software Engineering that monitors and improves the availability and performance of deployed software systems, often large software services that are expected to deliver reliable response times across events such as new software deployments, hardware failures, and cybersecurity attacks [1].
New Mexico State is moving on from athletic director Mario Moccia in the wake of an investigation that criticized the school's handling of the sexual abuse scandal that temporarily shut down the ...
Amad Diallo struck a 90th-minute winner as Manchester United staged a stunning late comeback to beat Manchester City 2-1 in the Premier League on Sunday. Four-time defending champion City led the ...
Executive Order 13772, titled "Core Principles for Regulating the United States Financial System", is an executive order signed by U.S. President Donald Trump on February 3, 2017.
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