publicado em 26/04/2011 às 17h40:00
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Foreign agencies discuss health surveillance in Brazil

Purpose is to discuss technical requirements and standardization of laboratories from national and international experiences

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Representatives from regulatory agencies in Switzerland (FDPH), U.S. (FDA) and European Community (EDQM) participate as speakers and panelists of the workshop on analytical laboratories of products subject to sanitary surveillance promoted by Anvisa.

The workshop aims to discuss the technical and standardization of laboratories from the national and international experiences. We seek more quality for monitoring security and compliance of the products we regulate, said Dirceu Barbano, director-chairman of Anvisa during the opening of the meeting.

The general manager of Public Health Laboratories (GGLAS), Lais Santana, and deputy director, Luiz Armando Erthal, emphasized the importance of the workshop to contribute to the contents of two motions that are in the Public Consultation (PC) in the Agency : the Public Consultations on 15 and 16.

Public Consultation No. 15 collecting suggestions for the future regulation of the Brazilian Network of Analytical Laboratories. CP 16/2011 is aimed at regulating the operation of analytical laboratories.

The representative of the Federal Public Health Agency of Switzerland (FDPH), Olivier Depallens, gave a brief history of the case that sparked concern about the quality of studies and tests developed by laboratories to assess the safety, toxicity and quality of products.

Depallens said that in 1970 the health authorities of suspected U.S. clinical trial information and other information supplied by the pharmaceutical industry in the process of drug registration. The results were disastrous. There were even false claims about diseases.

The representative of the FDA, Chidambaran Viswanathan, spoke about the regulation of analytical laboratories in the USA. Marta Miquel Figuerola, the EDQM, filed as are the European Community rules for these labs.

A Brazilian case of adoption of good laboratory practice is the first presentation on Tuesday (26 / 4). Fernando Mauro Spears will make a presentation on the Chromatography Laboratory at the Institute of Chemistry of Sao Carlos, Croma, which is linked to the University of São Paulo (USP).

Source: ANVISA
   Palavras-chave:   Meeting    Analytical Laboratory    FDPH    FDA    Anvisa    EDQM   
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