Animal tissues have been utilized in medical devices and pharmaceuticals for many years, but the change in the 'state of the art' has meant an understandable and justifiable increase in the awareness of safety issues.
Directives such as 2003/32/EC and Regulation 1774/2002 have steadily increased the burden on the manufacturer to demonstrate safety. Moreover, additional guidelines from the CVMP/CPMP, monographs from the EDQM, and standards covering viral contamination potentially add to the confusion. Was your medical device product in compliance before the October 2004 deadline? Is the EDQM procedure too much of a challenge?
In this audio conference, Phil Brown looks at the development of -- and explains the differences between -- the Directive, the Regulation and all the other documents, with the aim of providing some clarity.
Moving Target: Animal Tissue Regulations Update was presented on 2005-03-09 and is available for download, for more details please visit our site www.fxconferences.com
