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Conduct of a clinical pharmacology study
Is there a government authority regulating the approval and conduct of clinical pharmacology studies of drugs with a registration purpose? Yes, studies of registered drugs, that is to say, those drugs that will be later marketed in pharmacies are regulated and inspected by the National Administration of Drugs, Foods and Medical Devices (ANMAT).
What is a study inspection? Inspection: it is the procedure by which ANMAT performs an official review of the documents, facilities, records and any other resource related to the clinical study. Inspector: a person designated by the competent health and/or regulatory authority to conduct inspections.
What is an Ethics Committee? It is an organization, acting within its competence scope, which is independent from the sponsor and the investigator and which is composed of professionals who are doctors or scientists and by members who are neither doctors nor scientists. Its function is to provide a public assurance of the protection of the rights, dignity, safety and well-being of the participants of a study by means of, among other things, the review of the study protocol, the informed consent process and the investigator´s suitability.
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