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.¬†Marie Manley is Head of the Regulatory team at Bristows and has an in depth understanding of the new …

clinical trials briefing - another u turn for clinical trials regulation

It’s another U-Turn for Clinical Trials Regulation!

In May the EMA announced plans that clinical trial study reports could only be accessed via a ‘view on screen only’ mode, as per the new Clinical Trials Regulation. This was a seeming u-turn on their previous plans for transparency ¬†and aiding researchers in accessing information, thus giving rise to the European Ombudsmen and the IQWiG to attack the plans. …

clinical trials briefing, unblinding social media

Is Social Media Compromising Clinical Trials?

Pfizer’s head of Clinical Innovation for Worldwide R&D Craig Lipset, has suggested that the use of social media is ‘unblinding’ clinical trials, therefore compromising the integrity of the trial. As reported in an article by Outsourcing Pharma, through clinical trial participants discussing their treatment on social media, they are potentially coaching each other and causing a ‘false spike’ in reports …

EU Clinical Trials Regulation: Full Steam Ahead

The EU Clinical Trials Regulation will become a reality on 16th June 2014, although it will not take effect until mid 2016. The Regulation is outlined in the Official Journal of the European Union, repealing the old Clinical Trials Directive and replacing it with a streamlined one stop shop application process. Daniel Cooper a Partner at Covington & Burley has …

Download ebook: Top tips and ideas for compliance professionals

Download eBook > Regulatory non compliance costs the pharma industry billions in fines, audits and much more each year. To avoid these fines and bad reputation pharma companies rely heavily on their compliance teams, who provide oversight from R&D to the very end of a product cycle.  With the social environment changing, a growing demand for increasing transparency and increasing …