On 16th April 2014 the new EU Clinical Trials Regulation 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. Marie Manley is Head of the Regulatory team at Bristows and has an in depth understanding of the new Regulation and how it will affect commercially sensitive information contained in Clinical Study Reports, she has kindly written a detailed report on the perils of enhanced transparency for us.
- The concerns arising from enhanced transparency obligations
- Why enhanced transparency is problematic
- Enhanced transparency stalling the pace of innovation
- How does this affect the patients?
This interview provides a taster for the Clinical Trials Briefing on 9th September 2014 in London, which will discuss the multi faceted impact that the new Clinical Trials Regulation will have. Download the brochure now.