Regulatory Convergence

On behalf of Iperion, Frits Stulp joined the Regulatory Convergence in San Jose US, from the 16th to the 20th September as organized by the Regulatory Affairs Professionals Society (RAPS)Besides sharing the hands-on experiences of implementing IDMP requirements in Europe for comparison with US based companies, several exchanges took place in relation to Unique Device Identification (UDI) readiness. Overall, the level of UDI compliance already achieved in the US is likely to be a stepping stone for both UDI compliance in Europe (for pharmaceutical companies / medical device companies as well as for the device specific areas of IDMP).