Impact of trial design on GCP inspections - World Health Organization
Impact of trial design on GCP inspections - World Health Organization
Impact of trial design on GCP inspections - World Health Organization
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MARKETING AUTHORIZATION x<br />
MULTICENTRICAL STUIDES x <strong>GCP</strong><br />
INSPECTIONS<br />
•CLINICAL TRIAL MUST BE APROVED BY NRA OF ORIGIN<br />
COUNTRY<br />
•<strong>GCP</strong> INSPECTION (ANVISA OR NRA OF ORIGIN COUNTRY) IS<br />
NOT A MANDATORY REQUIREMENT DURING MARKETING<br />
AUTHORIZATION ASSESSMENT.<br />
•RESULTS VALIDATION x <strong>GCP</strong> INSPECTIONS<br />
Agência Naci<strong>on</strong>al<br />
de Vigilância Sanitária<br />
www.anvisa.gov.br
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