European Good Laboratory and Clinical Practices their relevance to clinical pathology laboratories
-
European Journal | European ti...
-
Europe has been drawing numerous consequences from last year's conflict in Georgia. The European Uni...
-
European Parliament Q
-
Javier Solana addressed the European Parliament on 08/04/2008. Q
-
European Parliament - Afghanis...
-
Javier Solana addressed the European Parliament on 08/04/2008. Extract on Afghanistan.
-
In the European Parliament (1)
-
EU High-Representative has participated in the European Parliament in a meeting on the Euro-Mediterr...
-
European Parliament Q
-
Javier Solana addressed the European Parliament on 08/04/2008 - Q
-
PubMed
(0) (0 Votes)Views: (1035) Date: (27-01-09) Pages: () -
Author: Dent NJ.
-
Abstract: European Good Laboratory and Clinical Practices: their relevance to clinical pathology laboratories. Dent NJ. Country Consultancy, Copper Beeches, Milton Malsor, Northants, England. The requirements for Good Laboratory (GLP) and Good Clinical Practices (CGP) were established as a matter of urgency by the United States in the early 1970s. These were in response to gross misconduct and, in many instances, fraud. Over the next 15 years, a plethora of regulatory principles, guidelines, and regulations was produced by many countries of the world, culminating in single standards for European, Japanese, and United States authorities. Although with regard to GLP this has basically become a worldwide recognized standard within the preclinical (toxicology) studies, in the veterinary, chemical, agrochemical, and pharmaceutical industries, the GCPs are now seeing a rebirth. Within a clinical trials environment, there is most certainly a requirement for compliance with GCP, especially with regard to the harmonization of data within the European Community. The goal of this article is to cover the following aspects: Why should we have good practices? Why should laboratory data be audited? Why is there a need for a QA unit or function? What is the QA operational approach? How does a laboratory audit take place within laboratories? In discussing the laboratories and their subsequent data audits, the pitfalls and benefits are addressed and an examination of the data from the sponsor's viewpoint is compared with that produced by the laboratory. The types of laboratories present in a clinical environment are examined. They obviously comprise clinical pathology, microbiology, and analytical as well as ancillary hospital areas such as X-ray and cardiology. These laboratories may also be in the private sector, the National Health Service, contract laboratories, universities, or the general practitioner population.(ABSTRACT TRUNCATED AT 250 WORDS) PMID: 1669972 [PubMed - indexed for MEDLINE]
- Resolved Question: european...?
what are some european foods and costoms? - Resolved Question: European...?
on my shoe. Why is that? (backs away slowly) - Resolved Question: What should European politicians do to prevent an Islamic takeover of Europe?
... aren't assimilating into European culture. Many of them fail to hold... - Resolved Question: How is the European Union trying to unite all the European countries?
How is the European Union trying to unite all the European countries? - Resolved Question: Which European country is comparable in size and population to England?
Which European country is comparable...England and one other European country. However, the... - Resolved Question: What is the difference between Western European and Eastern European Boxing?
...What is the difference between Western European and Eastern European Boxing? Bruce... - Resolved Question: What is the difference between European colonial architecture and Normal European styled buildings?
What is the difference between European colonial architecture and "Normal" European... - Resolved Question: Sovereignity of member states of the European Union is an illusion?
... of the European Union sovereign? Since...it eventually when the European Union is ... - Resolved Question: How is the European environment different than that in the United States?
How is the European environment different than that in the United States... - Resolved Question: What impact did European expansion into Africa, and is African culture better or worse now?
What impact did European expansion into Africa have on the Igbo and other tribes...
- European-Moroccan pact loosens fish, food trade
The European Parliament approved on Thursday a new fishing and farming accord with Morocco designed to reduce customs costs and boost trade across the Mediterranean. - European champs moved from Antwerp to Debrecen
The European swimming championships will be held in Debrecen, Hungary, after being moved Thursday from the Belgian city of Antwerp because of budget problems. Antwerp organizer Georges Straetemans, who is also vice chairman of the technical committee of the European swimming federation, said he could not bridge a financial shortfall of more than ?400,000 ($525,000). - European stocks sluggish over Greece fears
European markets pulled back from earlier gains Wednesday and the euro fell as concerns grew that Greece's creditors aren't ready to hand over bailout loans needed to avert a default and that the money might not be sufficient anyway. - European stocks mixed on Greek bailout delay
European shares mostly rose despite a Greek bailout hanging in the balance on Wednesday, with supportive Chinese comments lifting sentiment. - European stocks hit as Greek worries persist
European stock markets took a hit Thursday as investors ditched risky assets amid growing confusion and concern that a Greek debt bailout plan was falling apart. - European debt crisis: Greek bailout talks are complicated by looming deadline
ATHENS — As European leaders haggled Wednesday over how and whether to keep Greece from spinning into uncontrolled bankruptcy next month, one factor was not negotiable: the sheer passage of time, which is complicating efforts to ease Greece’s debts. Read full article >> - European stocks slip on ratings cuts, US data
European stocks slipped on Tuesday following disappointing US retail sales data, having largely taken in stride a Moody's ratings cut on six European nations overnight due to the eurozone crisis. - More Greek Delays Pressure European Shares
European shares and the euro dropped on Thursday after European officials once again delayed a decision on Greece's bailout, raising the risk that the country may default on a bond payment due next month. - European Stocks Decline on Greek Bailout Delay, Moody’s Review
European stocks fell as the region’s leaders delayed a Greek bailout and Moody’s Investors Service said it may downgrade global banks. U.S. index futures and Asian shares also declined. - European Melodrama: Falling GDP And Failing Greek Bailout Talks
European GDP fell 0.3% in the fourth quarter, beating expectations of a deeper decline and feeding bullishness, despite reports Greek might not get its bailout package just yet.