is being presented by Steve Coppock, MHS Auditor, with TÜV SÜD America, Inc and airs on Tuesday, October 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
Showing posts with label animal tissue. Show all posts
Showing posts with label animal tissue. Show all posts
Tuesday, September 13, 2011
Monday, November 3, 2008
Moving Target: Animal Tissue Regulations Update
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
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
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