Bio-IT World February 25, 2022
The clock is ticking on implementing the EMA’s IDMP standard. With the release of EU IG v2.1, the industry is in the final stages of preparations for optional submission. While regulatory teams have made progress applying guidance to uniquely identify products and standardize information, more work remains to establish a proper data foundation that supports submissions under the new requirements.
IDMP readiness will be dependent on the state of a company’s data. Leaders should be assessing data quality, ownership, and governance and evaluating how to bring together operational teams for better transparency and cross-functional collaboration. Whether you’re just getting started or deep in the weeds of implementation for IDMP, here are some practical tips that can help you prepare.