Brazil

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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Brazil

Legislations

CNS: Decree 98 830: Collection by Foreigners of Data and Scientific Materials in Brazil (1990) (Portuguese)

Regulations

CONEP: Resolution 196/96: Rules on Research Involving Human Subjects (1996)
Resolution 304/2000: On Complimentary Rules for Research Involving Indigenous People (2000)
Internal CONEP Regulation (2001) (Portugese)
Regulation of Resolution CNS 292/99 on Research with Foreign Cooperation (2002) (Portuguese)
Resolution 346/2005: On Multicenter Research (2005) (Portuguese)
CNS: Resolution 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests (1997)

Opinion Poll

Which of the following general ethical issues to conduct clinical trials?

	Widespread agreement that sound ethical standards must be observed in clinical research
	To participants subject irrespective of the geographic
	Economic setting in which Clinical Trial is undertaken
	Obtaining consent from a participant under access to better healthcare and payment
	A lack of appropriately trained people and resources in ethics committees

This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

Biomarkers World Europe (22/05/12)

World Gene Therapy Congress 2012 (22/05/12)

Exploratory Clinical Development World Europe (22/05/12)

World Animal Health Congress Asia (11/06/12)

World Vaccine Congress Asia 2012 (11/06/12)

Opinion Poll

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