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The ICH GCP guidelines:
- set standards for the design, conduct, monitoring and reporting of clinical research.
- guarantee that a submission in any ICH region will be approved for marketing.
- require certification of clinical research sites and investigators
- replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.

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Explanation:The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.        

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