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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
I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that…
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Erik Vollebregt
The seminar addresses the changes in the new medical devices regulation compared to current legislation. Speakers and their presentations: Sabine Hoekstra-Van den Bosch, Philips Healthcare Recast of Medical Device Directives Luc Sterkman,…
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Karin Verzijden
The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
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Carine van den Brink
The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
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Erik Vollebregt
In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share…
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Erik Vollebregt
ISO 14155, who in medical devices is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the…