The settlement provides for extensive corporate governance reforms directly connected to issues raised in the Complaint including the creation of a Risk Compliance Officer position and the engagement of an independent expert or entity to conduct yearly audits of the companys compliance with Good Clinical Practices
He will also provide compliance oversight of activities involving recognized quality standards, such as good manufacturing practices and good clinical practices
, as well as accreditations and industry certifications.
Prior to joining the company, Holland served as the Quality Assurance head of Good Clinical Practices
, Good Pharmacoepidemiology Practices and most recently, head of Good Laboratory Practices for Vertex Pharmaceuticals Inc, where she was a key to the strategy development and deployment of the company's GxP Quality Management System.
Who Guidelines for Good Clinical Practices
(GCP) for Trials on Pharmaceutical Products.
Dr Amiri said that in "addition to consulting patients, pharmacists need to be up to date on good clinical practices
, clinical standards, guidelines and drug safety.
Guidelines for Principles and Essentials of Good Clinical Practices
of Advanced Treatment Medicinal Products
However, in many cases these organisations have been found to be lacking in competence, infrastructure and good clinical practices
The drug discovery research will target 10 diseases, including cancer and cardiovascular disease, and the establishment of platforms for Good Laboratory Practices and Good Clinical Practices
Reference to REB review is also made under the section describing sponsors' obligations with respect to good clinical practices
Clinical trials must be conducted in compliance with good clinical practices
To start, the Code of Federal Regulations (CFR) items pertaining to Good Clinical Practices
(GCP) do not mention the term "quality" directly.