Just sitting at the airport after what was an excellent Global Harmonization Task Force Conference. Well done Steve Dibert and his crew, not to mention Health Canada. Who says regulatory affairs is boring! This conference really put the moose among the pigeons!
We had a truly gripping opening session from Dr. Robert Jackson, the renowned Orthopaedic Surgeon, reminding us where all this came from, followed by Chris Jarvis of the Canadian Rowing Team, astounding us with the story of how medical technology helps a Type 1 diabetic become a world class athlete.
Then followed Susan Ludgate pointing to the need to think more clearly on the role of post market clinical data, through Michael Gropp's pointing to the mounting auditing burden, all the way to the big question of what to do now with the GHTF. Do we keep it? Bin it? Or make it into something else? No clear answer other than it was saved from the bin. So will a future GHTF be a real force for value, and fewer unnecessary burdens for manufacturers and authorities, or will it be just more of the same? Watch this space!
John Brennan
Director Regulatory and Technical Affairs