Best practices emerge from success stories
“Experts do need a safe place where to exchange best practices on the regulatory qualification of these emerging technologies; #dHealth4Trials channel is the answer,”
said Dr. Wim Darte, Regulatory Affairs at Novartis Pharma AG and co-lead with Prof Marco Viceconti of the Regulatory activities in the Mobilise-D project.
Indeed, the channel will take its first steps from the recent success story of Mobilise-D and its request for qualification advice to EMA for the use of wearable sensors to quantify digital mobility outcomes and their use as biomarkers in regulatory drug trials.