Yesterday the European Medicines Agency’s (EMA’s) long awaited policy 0070 went live. I have previously described the policy, its aims, advantages, possible limitations, and potential impact on everyone here and […]
Health Canada seems to want to have it both ways: be seen as a regulator that serves the public interest through a progressive commitment to transparency, yet be trusted by […]
The institution of the European Ombudsman celebrated its first 20 years of activity with a party for staff and all those who have and still are contributing to its work. […]
In late 2010, the European Medicines Agency (EMA) became the first regulator in history to promulgate a freedom of information policy that covered the release of manufacturer submitted clinical trial […]
Following on from its recent webinar I blogged about, the European Medicines Agency (EMA) held a consultation meeting with industry and selected stakeholders to discuss specific aspects of its policy […]
After attending a webinar on the European Medicines Agency’s (EMA) new 0070 policy, which formalises the release of regulatory data held by the EMA, some of my earlier doubts have […]
In October 2014, the European Medicines Agency (EMA) promulgated its policy 0070 on the release of regulatory data acquired and held in the course of its regulatory function. At the time, […]
European regulatory agencies frequently inform doctors and pharmacists about their activities, paying particular attention to pharmacovigilance. The Italian Medicines Agency (AIFA) started a new information feed on 3 April 2012: […]
It’s hard to imagine a restaurant without a menu, a sheet where the fare is listed, where the ingredients are explained, and limitations are clearly labelled (“not for people with […]
The European Medicines Agency (EMA) has now released the final version of its policy on the prospective release of clinical reports of trials, which are submitted by sponsors to support marketing authorisation applications […]
