is being presented by Dr. Elliot Lawrence, Associate Director of Regulatory Affairs , with ERA Consulting (UK) Ltd. and airs on Tuesday, July 13th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.
This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.
Showing posts with label ATMP. Show all posts
Showing posts with label ATMP. Show all posts
Tuesday, June 8, 2010
Friday, April 9, 2010
Navigating the EU Regulatory Pathway for Advanced Therapy Medicinal Products
is being presented by Damien Bové, Consultant, Medical Tech Development & Regulations and airs on Thursday, May 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
Wednesday, June 17, 2009
EN 1394:2007 - A New Dawn for Human Tissue in Europe
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
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
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.
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