The Center for Professional Innovation and Education Launches Two New Courses on International Regulatory Affairs Issues for Life Sciences Personnel
28 November 2007
The Center for Professional Innovation and Education (CfPIE) today announced the introduction of two new training programs. 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.
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 the Far East 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 on April 8th and 9th, 2008 and Latin America – Understanding Regulatory Compliance Requirements is scheduled for April 10th and 11th, 2008. Both courses will be held at The Desmond hotel and conference center in Malvern, PA.
