Regulation

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 […]

Last night I attended BVMed’s well attended debate looking at the German medical technology sector in times of the economic crisis. The debate was hosted by the permanent representation of the German Federal State of North Rhine Westfalia. Member of the European Parliament, Dr Peter Liese, was one of the speakers. He welcomed BVMed’s initiative […]

Just back from Easter holidays and picked up this article from the Wall Street Journal “Medical Devices Face New Scrutiny From FDA”.  When I read the article it reminded me again of one of the great untold strengths of device regulation in Europe and yet another example where the European system is better than the […]

Brussels, 8 April 2009 – Eucomed welcomes revision of directive 2000/35/EC on Late Payments adopted by the European Commission today strengthening current payment obligations. Association disappointed to see final text considerably watered down compared to initial clear targets. As the voice of the medical technology industry in Europe, Eucomed is extremely pleased to see late […]

From 23 – 25 March 2009, the Drug Information Association (DIA) held its annual EuroMeeting in Berlin. During the presentation by Richard Moore, Institute of Nanotechnology, I learned that prescription drugs prove to be ineffective in 30% – 60% of patients1 and that 16% of the drugs approved in the USA are linked to severe […]

On one of those beautiful clear Spring mornings here in Brussels, it was a rare pleasure to head out early for breakfast with the Health Consumer Powerhouse. Housed in a beautiful high ceilinged and gilt embellished office near De Brouckere, Health Consumer Powerhouse is a champion for European consumers of healthcare (you and me) and […]

It was with some trepidation that I placed myself in the ‘lions  den’ of the pharmaceutical industry at the annual Euromeeting of the Drug Information Association in Berlin today. Sharing a platform to discuss the evolution of medical device regulation with Mdme Georgette Lalis of the EU Commission and David Feigal, former FDA Commissioner, proved […]