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A year on and the mood music in Washington is very different. My return to this beautiful city, where fall colours are emerging in their full majesty, has seen a very different atmosphere from a year ago when the Obama health reforms were on their way and universal coverage seemed a very real probability. The […]

Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time […]

The 7th European Healthcare Fraud & Corruption Network conference took place in Brussels at the end of September and featured high level speakers and experts. The event proved to be an ideal platform for discussing a number of topics of relevance to all the stakeholders in the healthcare system. The “Conflicts of Interest” session was […]

The occasion of the annual visit of the European Chamber of Commerce in Europe afforded me the rare opportunity to meet both a group of senior industry leaders from China and the Chinese ambassador to the EU, and his trade officials. What was clear from this excellent opportunity to gain first hand insights on the […]

The blogosphere has been driven into a foment over the last week or so by a paper by Groeneveld et al entitled ‘Increasing Use of Cardiovascular Devices and Rising Health Costs’. Its conclusions are interesting but, I suggest, not conclusive of anything which should prompt policy makers to ask further questions. Discounted for inflation the […]

In an ideal world we would have the same rules on devices in each country.  As patients, as we live or travel in different countries, we can be confident that should we fall ill, the devices used to help us are as safe as the ones at home.  As businesses, we would be confident that […]

On the 29th October all the votes were in and it seems that nothing more than EU paperwork stands between us and our first compulsory European database for medical devices, the infamous ‘Eudamed’ database. I say compulsory because ‘Eudamed’, as our European device database is known, has been in place for many years, but it […]

On Thursday 11 June, I attended, as part of the EULAR conference in Copenhagen – Europe’s largest conference on Rheumatology – the session “Structure modification in osteoarthritis: Time to update the guidelines”. What became really apparent was that rheumatologists from Europe and North-America are seriously concerned about the exponentially increasing prevalence and incidence of osteoarthritis […]

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 […]