Good Clinical Practice Directive
In today's world, Good Clinical Practice Directive has become a topic of great relevance and interest to a wide variety of people. Whether due to its impact on society, its historical relevance, its importance in the scientific field or its influence on popular culture, Good Clinical Practice Directive has captured the attention of millions around the world. This article seeks to thoroughly explore all aspects related to Good Clinical Practice Directive, analyzing its impact in different areas and offering a comprehensive and in-depth vision of this fascinating topic. From its origins to its current relevance, this article aims to provide a complete and detailed perspective on Good Clinical Practice Directive, offering readers a broader and richer understanding of this phenomenon.
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.
The directive deals with the following items:
- Good clinical practice for the design, conduct, recording and reporting of clinical trials:
- Good Clinical Practice (GCP)
- The Ethics Committee
- The sponsors
- Investigator's Brochure
- Manufacturing or import authorisation
- Exemption for Hospital & Health Centres and Reconstitution
- Conditions of Holding a Manufacturing Licence
- The Trial master file and archiving
- Format of Trial Master File
- Retention of Essential and Medical Records
- Inspectors
- Inspection procedures
- Final provisions
References
- Text of the directive: Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
- National implementing measures of the EU-countries