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Impact of trial design on GCP inspections - World Health Organization

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REGULATION FOR BIOMEDICAL RESEARCH IN<br />

HUMAN SUBJECTS<br />

LAW 6360/76 - HEALTH SURVEILLANCE<br />

RDC 305/2002<br />

BSE<br />

RDC 68/2003<br />

BSE<br />

RDC 350/2005<br />

Imports<br />

Agência Naci<strong>on</strong>al<br />

de Vigilância Sanitária<br />

R CNS 370/2007<br />

CEP-CONEP<br />

RDC 39/2008<br />

Clinical Trials<br />

R CNS 346/2005<br />

CEP-CONEP<br />

R CNS 196/1996<br />

BIOMEDICAL RESEARCH IN<br />

HUMAN SUBJECTS<br />

R CNS 251/1997<br />

New medicines<br />

R CNS 292/1999<br />

Internati<strong>on</strong>al<br />

Cooperati<strong>on</strong><br />

R CNS 340/2004<br />

Human Genetics<br />

R CNS 301/2000<br />

Placebo<br />

www.anvisa.gov.br

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