European Forum for Good Clinical Practice
Encyclopedia
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research
in Europe
. The EFGCP is committed to the development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad.
Clinical research
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use...
in Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
. The EFGCP is committed to the development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad.
See also
- Clinical siteClinical siteA clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...
- European Clinical Research Infrastructures Network (ECRIN)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA, EU) - European and Developing Countries Clinical Trials PartnershipEuropean and Developing Countries Clinical Trials PartnershipThe European and Developing Countries Clinical Trials Partnership or EDCTP is a partnership between the European Union , Norway, Switzerland and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccines...
(EDCTP) - EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- Good Clinical PracticeGood clinical practiceGood Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
(GCP) - Harmonization in clinical trials
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Inverse benefit lawInverse benefit lawThe Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed...
- Quality assuranceQuality AssuranceQuality assurance, or QA for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process...
- Standing operating procedureStanding operating procedureThe terms standard operating procedure or SOP, is used in a variety of different contexts, such as healthcare, education, industry or the military. The military uses the term Standing Operating Procedure- rather than Standard- because an SOP refers to an organization's unique procedures, which are...