Eighth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine

EMA is hosting the eighth industry stakeholder platform on the operation of the centralised procedure for human medicines on the 27 June 2022. This belongs to a series of regular meetings between regulators and representatives of industry stakeholder organisations, aiming to foster a constructive exchange on general matters of common interest and more focused discussions on specific processes and issues to support continuous improvement.

This meeting will focus on the EMA’s Raw Data project - Information on upcoming proof-of-concept pilot and the International OPEN Project. A series of updates on the implementation of the new Working Parties Governance implementation model, on the development of the Quality Innovation Group (QIG), on the IRIS Platform and also updates on the EMA’s implementation of Medical Device Regulation. In addition, there will be discussions on changes to the RMP publication in EPAR’s and the predictability on marketing authorisation submissions.