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Karin Verzijden
The role of national customs and self-regulatory bodies Introduction Recently, the Rotterdam District Court decided a dispute between Omega Pharma and Procter & Gamble on allegedly misleading advertising of food supplements. The…
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Erik Vollebregt
Are you still with me on where we are with the EU revision of medical devices and IVD legislation? If you are, you have strong tolerances for fast moving complexity – congratulations!…
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Erik Vollebregt
This seminar addressed the review of the regulatory requirements for clinical trials. Speakers and their presentations: Joris Bannenberg, Factory-CRO Developments in Clinical Trials for Medical Devices Erik Vollebregt, Axon Lawyers Clinical Trial…
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Erik Vollebregt
After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you…
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Erik Vollebregt
We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective. The previous last important iterations in the legislative process are the EP’s plenary vote on…
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Erik Vollebregt
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…
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Erik Vollebregt
This spring holiday I took the recently published Study on Corruption in the Healthcare Sector with me as holiday reading and that proved a good choice. The 332 pages long study was commissioned…
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Karin Verzijden
After a succesful Autumn College last year September, this 2 days event on EU Food Law is repeated under the name Spring College. The event will take place on 27 and 28…