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.