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Erik Vollebregt
The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start…
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Erik Vollebregt
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all…
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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
Yet another post! Apologies, I am very productive these days. A lot is happening and I am just trying to keep track because the moment is NOW if we don’t want to…
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Erik Vollebregt
I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in…
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Erik Vollebregt
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary…
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Erik Vollebregt
In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to…
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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…