Revision of the Medical Devices Directives – A New Regulation

Jun 10, 2013

Without doubt, the most significant pieces of legislation to come under the radar for revision in the past number of years are those concerning the regulation of medical devices. Michelle O’Connor of ICON Clinical Research discusses how the new Regulation also builds in contributions to ...

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Paediatric Clinical Trials: Need for Capacity Building

Jun 10, 2013

The EU Paediatric Regulation mandates that all new medicinal products are also evaluated in all paediatric age groups, unless an exemption (waiver) is obtained from the European Medicines Agency (EMA). This has led to an increased need to conduct clinical trials in children within and ...

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