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.
This audio conference covers:
- The current landscape of tissue engineering regulations
- ATMP regulations and how they will impact the human tissue industry
- How directive 2004/23/EC will dovetail with thy ATMP, and the issues that this presents
- The ATMP's effect on non-viable tissue standards
About the speaker:
Phil Brown has been the Director of Regulatory Affairs, Quality Assurance and Reimbursement for Wright Medical in Europe since October 2007. His responsibilities include Wright's human tissue products as well as the rest of the orthopaedic portfolio.
Phil has over 17 years of regulatory affairs experience, 12 of them working directly with combination products as well as human and animal tissue products.
Throughout his career, Phil has been actively involved in European industry efforts to develop and define future European requirements for 'appropriate' regulations, both at Trade Association and European Commission levels. Phil holds a degree in Chemistry and frequently lectures and writes on European tissue regulatory issues.
Who should attend?
- Regulatory Affairs Managers
- Quality Managers
- Tissue Bank Directors
- Senior Regulatory Directors
- Tissue Logistics Personnel
This audio conference is rated General Interest.
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.