1 Marie Manley, Partner, Bristows, on the EU Clinical Trials Regulation
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Marie Manley, Partner, Bristows, on the EU Clinical Trials Regulation

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An Interview with Marie Manley, Partner, Bristows, on the EU Clinical Trials Regulation

On 16th April 2014 the new EU Clinical Trials Regulation was adopted, however it will not apply until 2016. This new Regulation replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU, making cross border trials easier.
The Regulation also adopted new Clinical Study Report transparency measures, which have raised questions as to the commercially sensitive information they contain making the Life Sciences industry worried about how the Regulation will work in its final form.

In this report we speak with Marie Manley, Partner at Bristows, about the new EU Clinical Trials Regulation and whether it is a positive move forward.

Download the report now to hear Marie's insights on:

  • The concerns arising from enhanced transparency obligations
  • Why enhanced transparency can be problematic
  • If enhanced transparency stall the pace of innovation
  • The effect on the patient

Join us in London on 9th September at the Clinical Trials Briefing to learn how the new regulation impacts clinical trial processes, from a new one stop portal system, to commercially sensitive information and conducting trials across borders.
 
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