The work done by the Mobilise-D consortium is taken as an example of successful interaction with EMA in the marketing authorisation application (MAA) process.
"Regulatory agencies can provide advice to support developers of digital technologies for medicines use, but what are the best strategies to maximise the chance of a successful regulatory interaction?"
In a recently published Nature Reviews article, EMA and industry representatives comment on the experience so far, taking as a positive example the work done by Mobilise-D, a project funded by the Innovative Medicines Initiative (IMI) to develop a digital mobility assessment system applicable across conditions for which measures of mobility loss can be related to disease progression.
Read the full article here
