The 10th Global Harmonization Task Force (GHTF) Conference

Working towards harmonization in medical device regulation
June 28 – 30, 2006, Musik- und Kongresshalle Luebeck, Germany

Design for Patient Safety in a Global Regulatory Model

The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia Pacific (Australia, Japan) and North America (Canada, USA), each of which actively regulates medical devices using its own unique regulatory framework.

The goal of the GHTF is to provide a forum for representatives of member regulatory authorities and industry representatives to work together to encourage convergence in regulatory practices related to ensuring safety, effectiveness, performance and quality of medical devices in ways that protect public health, promote technological innovation and facilitate international trade. This is accomplished via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents are developed by five different GHTF Study Groups. The documents – approved by the GHTF Steering Committee – can then be adopted / implemented by member regulatory authorities.

The European Commission is currently holding the rotating Chair of GHTF for Europe and is organizing the 10th GHTF Conference, which will be held in Luebeck, Germany, from Wednesday 28th to Friday 30th June, 2006. “Patient Safety” is the overriding theme of the European Chair and, appropriately, the Conference is entitled “Design for Patient Safety in a Global Regulatory Model”. This conference will be the flagship event of the European Chairmanship of GHTF. The GHTF Conference serves as a forum for informational exchange in which conference participants from the medical device industries meet the representatives of the medical device regulatory authorities. Explore more detailed information on the exciting and interactive programme on the GHTF website: www.GHTF.org