The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform how clinical trials are initiated, designed, and run. This initiative, accelerating Clinical Trials in the EU (ACT EU), aims to further develop the European Union as a focal point for clinical research, promote…
Research is a strange thing. Some people think research is too slow and too complicated. Others are sceptical and wouldn’t like to be the guinea pig. From the point of a clinician the most important goal in doing research is: Do no harm! Issue Nr. 4-2021 of the OIFE Magazine is dedicated to research and…
November 9th and 10th OIFE was represented by Ingunn Westerheim at the Council of Federations (CEF) meeting of EURORDIS – the European umbrella organization for rare conditions. The socalled CEF is a forum where umbrella organizations and federations for rare conditions in Europe come together to learn about news in the European rare disease field…
The IMPACT Survey is a joint initiative between OIFE, OIF & Mereo BioPharma. The survey will be launched in summer 2021 and we will need the help of all our member organizations and the OI-community to spread the word and encourage as many people with OI (and parents) to fill in the survey. Written by…
We bring you the following message from European Medicines Agency (EMA): “The EMA needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA will only approve a vaccine for COVID-19 after a thorough evaluation…
The OIFE will update this page with links to resources about COVID-19 and osteogenesis imperfecta. We have created a shortlink to this page to make it easier to remember. If you type in the following in your browser, you will be redirected to this page oife.org/covid19 See also more resources about Covid19 in English from…
On November 30th OIFE was represented at an interactive meeting about Orphan Drugs hosted by the European Medicines Agency (EMA). Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of rare diseases. There are currently two designated orphan drugs being investigated in OI, the most known being setrusumab from Mereo Biopharma. Products for…
Can patient engagement foster access? On September 24th representatives from OIFE attended a very interesting webinar on pricing of rare disease drugs. It was called “How patient engagement can foster access through improved affordability” and included lectures from pharma companies, patient experts and health economists. The speakers raised a lot of important questions like: What…
The European Medicines Agency (EMA) was founded in 1995, and since then has worked across the EU and globally to protect public and animal health by assessing medicines and by providing independent, science based information on medicines. In 2000, patient representatives joined for the first time as members of one of EMA’s scientific committees. Today,…
