1 Clinical Trials Regulation Top Ten Key Issues
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Clinical Trials Regulation Top Ten Key Issues

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Outlining the key issues to be considered in light of new EU Clinical Trials  Regulation

On 16th April 2014 the new EU Clinical Trials Regulation (CTR) was adopted. This new regulation, which comes into force in 2016, 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 (CSR) 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 look at some of the impacts that the CTR has had, both negative and positive. Whilst some issues are already resolved others are still ongoing and therefore hard to predict the outcome.
This Ebook also features a running Contribution from Dr Wolfgang Rehmann of Taylor Wessing


Download the report now to learn more, including:

  • Privacy versus Transparency
  • Secondary Research Considerations
  • Whether or not the new Regulation goes far enough
  • Simplifying Cross Border Trials

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.
 
Download the Ebook to gain your 15% discount. Book now!