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
Showing posts with label Phil Brown. Show all posts
Showing posts with label Phil Brown. Show all posts
Wednesday, June 17, 2009
Friday, November 21, 2008
Navigating the European Human Tissue Maze
The European regulatory requirements over the past 10 years covering products using human tissue has been more than a little confused. Excluded from the Medical Device Directive, and not always appropriate to pharmaceutical rules, product manufacturers have had to deal with a raft of national regulations ranging from 'non-regulation' to 'medicines regulation'.
Although pan-European regulation has been mooted, the confusion is set to continue for at least two more years. In this audio conference, Phil Brown describes how this maze of regulation came about, as well as how the current European map offers opportunities for product introduction.
Navigating the European Human Tissue Maze was presented by Phil Brown, Sr. Consultant, with Quintiles Consulting on 2005-02-09. For more details on this conference, or to purchase a download, please visit our site www.fxconferences.com
Although pan-European regulation has been mooted, the confusion is set to continue for at least two more years. In this audio conference, Phil Brown describes how this maze of regulation came about, as well as how the current European map offers opportunities for product introduction.
Navigating the European Human Tissue Maze was presented by Phil Brown, Sr. Consultant, with Quintiles Consulting on 2005-02-09. For more details on this conference, or to purchase a download, please visit our site www.fxconferences.com
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
Wednesday, June 25, 2008
EN 1394:2007 - A New Dawn for Human Tissue in Europe
The last 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.
This audio conference is presented by Phil Brown of Wright Medical. Learn more at www.fxconferences.com.
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.
This audio conference is presented by Phil Brown of Wright Medical. Learn more at www.fxconferences.com.
Subscribe to:
Posts (Atom)