OIFE at the EMA
On July 9th 2019 the OIFE was represented by our honorary member Taco van Welzenis in a meeting at the European Medicines Agency (EMA). The EMA is an agency of the European Union in charge of the evaluation and supervision of medicinal products. They used to be located in London, but has recently moved to Amsterdam, the Netherlands. Their counterpart in the USA is the The Food and Drug Administration (FDA).
The purpose of the meeting on July 9th was to provide input to EMA’s scientific advice concerning a surrogate endpoint for clinical trials in OI. An endpoint is the primary outcome that is measured in a clinical trial. In clinical trials, a surrogate endpoint is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. Taco’s role was to give input from the patient perspective.
Scientific advice at the EMA
So where in the process of developing a new drug does scientific advice take place? Below you can find a description of the different steps in the process behind medicines for human use that are authorised via EMA. The illustration is taken from the brand new EMA booklet “From laboratory to patient: the journey of a centrally authorised medicine”.
Are you interested in patient involvement?
Are you interested in being a patient representative and taking part in meetings in the EMA or in research and development related to OI or other rare bone diseases? Then please contact the OIFE by sending an email to email@example.com
How are medicines approved by the EMA?
Do you want to learn more about how a new medicine is approved by the European Medicines Agency in a quicker way?
Then you can find out more by watching the video below.