The previous 18 months has seen a huge leap forward in the regulation of human tissue products, through the publication of the Advanced Therapy Medicinal Product Regulations (ATMP). In parallel, the European Commission has expanded the directive 2004/23/EC into two technical directives, which detail requirements for ensuring public health when using human tissue from donation to distribution.
No longer will Europe be faced with a fragmented regulatory approach to human tissue products, it will have a unified system based on the free movement of human tissue across European borders.
EN 1394:2007 - A New Dawn for Human Tissue in Europe was presented by Phil Brown, Director of Regulatory Affairs, with Wright Medical and aired on 2008-07-02. For more details or to download this audio conference, please visit our site at www.fxconferences.com
