Clinical Trials

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Axon Seminar Clinical Trial Data 9 April 2014

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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What will the Intermune and Abbvie cases mean for the medical devices industry?

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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Axon Seminar Medical Devices Wednesday 14 November 2012

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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Axon Seminar Cell-based Therapies Wednesday 18 April 2012

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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Axon Seminar Cell-based Therapies Wednesday 18 April 2012

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…

Article

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

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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ISO 14155:2011 is here: revised standards for medical devices clinical trials

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…

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