European Union Good Clinical Practice

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... [Pg.392]

The European Union Directive on Good Clinical Practice in Clinical Trials Implications for Future Research... [Pg.463]

European Parliament and the Council of the European Union (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (http //pharmacos.eudra.Org/F2/eudralex/vol-l/DIR 2001 20/DIR 2001 20 EN.pdf)... [Pg.171]

EC (1991) European Union Note for Guidance. Good Clinical Practice for Trials on Medicinal Products. Brussels European Commission. [Pg.447]

Big Chemical Encyclopedia