Product category:
Laboratory and scientific training and education
News Release from: Center For Professional Innovation and Education | Subject: International regulatory affairs courses
Edited by the Laboratorytalk Editorial
Team on 30 November 2007
International regulatory affairs for
life sciences
CfPIE launches two new courses: Japan - regulatory filing requirements and compliance processes for life sciences, and Latin America - understanding regulatory compliance requirements
The Center for Professional Innovation and Education (CfPIE) has announced the introduction of two new training programmes The courses, Japan - regulatory filing requirements and compliance processes for life sciences, and Latin America - understanding regulatory compliance requirements, are intended to give life sciences personnel an overview of regulatory compliance in two rapidly growing regions of the world
This article was originally published on Laboratorytalk on 6 Jan 2004 at 8.00am (UK)
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As firms develop products for markets in Japan and Latin America, they are finding specific regulatory challenges in these regions that were not necessarily present when marketing drugs, devices and other therapeutic products in Europe and North America.
This has resulted in some confusion over which new protocols need to be implemented for compliance and which existing measures will satisfy regulators in those markets.
"With the proliferation of pharmaceutical, biotech and medical device firms in Asia and Latin America, and with more established firms marketing products to these regions, there is clearly a need for training on local regulatory requirements." said Bill Beyer, director of marketing for CfPIE.
"Regional regulatory mandates are often very specific and can differ from country to country.
"With these two new courses, we are providing a comprehensive, introductory overview on local requirements".
Japan - regulatory filing requirements and compliance processes for life sciences will be offered 8 and 9 April 2008, and Latin America - understanding regulatory compliance requirements is scheduled for 10 an d 11 April 2008.
Both courses will be held at the Desmond Hotel and Conference Center in Malvern, PA, USA.
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