Chile

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Process validation

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

Chile

Legislations

Law No. 26.027 (2005)
Law for the Protection of Private Life No. 19.628 (1999) (Spanish)

Regulations

Supreme Decree No. 42 (1986)
Supreme Decree No. 1.935 (1993)
General Technical Rule No. 2 of the Ministry of Health (1993)
Exemption Resolution No. 134 (1994)
Supreme Decree No. 494 (1999)
Exemption Resolution No. 1.856 (1999)
Resolution No. 2.085 of the Ministry of Health (2001)
Technical Rule No. 57: Regulation of the Conduct of Clinical Trials that Use Pharmaceutical Products in Human Beings (2001)

Guidelines

Ethical Guidelines for Clinical Trials with Pharmaceutical and Biological Products (2001)

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

Links