Clinical Trials Briefing - Marie Manley Ebook

Download Ebook: Navigating the Perils of the Clinical Trials Regulation

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.┬áMarie Manley is Head of the Regulatory team at Bristows and has an in depth understanding of the new …

Clinical Trials Briefing - Top Ten Key Issues

Download Ebook: Top Ten Key Issues Regarding EU Clinical Trials Regulation

The EU Clinical Trials regulation was adopted on 16th April 2014 and comes into force in 2016. It replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU. Although it is a positive move forward, it brings with it, its own issues, from protecting commercially sensitive information to setting up a new ‘one stop’ …