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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.
GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: [6] Disclosure of conflict of interest; Public disclosure of study design; Benefit for populations in which research is conducted; Reporting of accurate results and publication of negative ...
The aim is the reduction of hazardous substances in vehicles to minimise their release to the environment. Vehicles should be designed to facilitate proper dismantling and to allow components and materials to be reused, recycled and/or recovered. The producers (both vehicle and component) shall increase the demand for recycled material.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7; Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8; Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5; Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
Guidance, navigation and control (abbreviated GNC, GN&C, or G&C) is a branch of engineering dealing with the design of systems to control the movement of vehicles, especially, automobiles, ships, aircraft, and spacecraft. In many cases these functions can be performed by trained humans.