It has been over a year since the EMA implemented Policy 0070 on the Publication of Clinical Trial Data; the EMA have published a guidance document and a report of the first year since it was launched (Oct 2016-Oct 2017). Under Policy 70, clinical data has now been published for over 50 products,...
Carole Pugh and Karen Goode of EUDRAC attended the recent reception hosted by Prince Charles at Buckingham Palace to celebrate the winners of the 2018 Queen’s Awards for Enterprise. The reception was held in the impressive state rooms at Buckingham Palace with the Duke of Kent also in attendance...
EUDRAC will be exhibiting at the annual DIA Annual Meeting in Boston, United States of America from 24th to 28th June 2018. Our team would be pleased to welcome you at booth number 1143 to discuss your potential regulatory affairs, pharmacovigilance and publishing needs. A member of our Management...
EUDRAC recently collaborated on a successful PRIME application with The EspeRare Foundation , a Swiss not-for profit Biotech Company which develops existing therapies to address severe unmet therapeutic needs in rare diseases. The application was for a protein replacement therapy (ER004) for X-...
EUDRAC attended the MHRA GPvP Symposium on Pharmacovigilance in May 2018. Click here for an document outlining of some of the common inspection findings. Please contact us directly for further information or for queries on how EUDRAC can assist you with your pharmacovigilance needs.
EUDRAC recently attended the DIA Europe meeting in Basel. One of the most popular sessions was 'EMA Relocation and Implication for Centralised Activities’. Please see here for a summary of the discussions.
This website uses cookies to ensure you get the best experience on our website. Read more. Got it