People In Brief

GHTF selects new heads: FDA Office of Science & Engineering Laboratories Director Larry Kessler is appointed chair of the Global Harmonization Task Force, effective Jan. 1. For the next 18 months, Kessler will serve alongside AdvaMed's Executive VP-Technology & Regulatory Affairs Janet Trunzo in her recently announced position as GHTF vice chair to promote the convergence of global regulatory practices for the medical device industry. Since its founding in 1992, the voluntary group of medical device regulatory authorities and trade associations from the United States, Europe, Canada, Japan and Australia has issued a variety of harmonized guidances on the safety, effectiveness and quality of medical devices, promotion of technological innovation, and international trade. Kessler, who replaces outgoing GHTF Chair Georgette Lalis from the European Commission, previously headed a GHTF study group that set a standard for a unified, international system for reporting medical device adverse events and established the National Competent Authority Reporting program for regulators to share post-market information...