Impact of trial design on GCP inspections - World Health Organization

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CLINICAL TRIALS TO BE CONDUCTED IN BRAZIL WITH DRUGS OR MEDICAL DEVICES REQUIRE AUTHORIZATION FROM ETHICAL INSTANCE AND ANVISA Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
ETHICAL OVERSIGHT - SYSTEM OF ETHIC COMMITTEE Agência Nacional de Vigilância Sanitária CEP/CONEP SYSTEM Regulated by NATIONAL HEALTH COUNCIL • National Commission <strong>of</strong> Ethic in Researches – CONEP - It is an advisory, deliberative, regulatory, educational, independent organ reporting to the National Council <strong>of</strong> Health- MAJOR INSTANCE- MANDATORY FOR INTERNATIONAL COOPERATION • ETHIC COMMITTEES IN RESEARCH – CEPs – LOCAL INSTANCE www.anvisa.gov.br
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Page 5 and 6: GUIDELINES FOR, NON CLINICAL STUDIE
Page 7 and 8: •INVESTIGATOR •CRO •SPONSOR A
Page 9 and 10: REGULATORY OVERSIGHT OF CLINICAL TR
Page 11 and 12: INTERNATIONAL COOPERATION Agência

Impact of trial design on GCP inspections - World Health Organization

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