This is a brief one. EFPIA - the European Federation for Pharmaceutical Industries and Associations - has this morning launched a manifesto for putting pharma at the heart of evonomic growth in the European Union (EU). http://www.efpia.eu/uploads/documents/EFPIA-health&growth_MANIFESTO_V11_pbp.pdf It's a comprehensive tome. With laudable recommendations and objectives on many things I would agree with it on … Continue reading Pharmadrama – it’s not what you do it’s the way that you do it @EFPIA @PMLiVEcom
The European Medicines Agency (EMA) has published the note of the conference held in London a few weeks ago, about its plans for proactive publication of clinical trial data. It is now setting up five advisory groups and inviting self-nominations from people to join these. You will find the following listing of the advisory groups, plus … Continue reading Patients need apply – European Medicines Agency (EMA) next steps on clinical trial data
First, a brief history of time in the Europe Union (EU). It goes slowly. That's it! For the last two years or so the European Commission has been consulting on plans to revise the European Clinical Trials Directive. The Directive has been in force since 2001. Researchers hate it. To be fair so do many … Continue reading At last! A patient-centred statement on the proposed EU Clinical Trials Regulation
Yes, that is a long headline is it not? PharmaTimes and others cover a paper in PloS Medicine authored by a number of medicines regulators including the European Medicines Agency (EMA), calling for openness in raw trial data. The three pronged approach they suggest looks like a good basis for discussion. It would be interesting … Continue reading Regulators push openness agenda on raw trial data…and EUPATI issues call for examples of educational materials on medicines development
So I saw this on the Research America blog and I thought it worth posting. The Health Affairs article referred too can be found here. It is unsurprising but nonetheless disappointing that the article does not go into detail about the reasons for the slower adoption in Europe. There will be some geographic-specific and also … Continue reading Why are EU patients having to wait so long for cancer medicines?