Chaturvedi will be responsible for developing, implementing and monitoring global policies and procedures to assure worldwide compliance with good clinical practices
(GCP) and the laws and regulations governing drug development.
Research and good clinical practices
are a crucial element of health care in the UAE and we are committed to it.
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.
Do results reinforce good clinical practices
that have been used for some time or do they suggest a major change in practice?
Another important aspect of this service is the guaranteed fulfillment of high quality assurance standards, including Good Clinical Practices
(GCP) and other specific regulatory requirements.
The ISO (International Organization for Standardization) standards for quality management systems (QMS) serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices
(GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies.
One other important gap is the absence of discussion of India's ongoing regulatory challenges relating to both Good Manufacturing Practices (GMP) and Good Clinical Practices
Guidelines for Auditing of Good Clinical Practices
of Laboratories Participating in Clinical Drug Trials
The Data Safety Monitoring Board (DSMB), an independent group of experts established to protect the participating infants' rights and needs during the Phase III trial, determined that the trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices