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

EMA is hosting the Industry stakeholder platform on the operation of the centralised procedure for human medicines on the 24th November 2022. This will be the 9th in a series of regular meetings between regulators and representatives of industry stakeholder organisations, aiming to foster a constructive exchange on general updates and more focused discussions on specific processes and issues to support continuous improvement.

This meeting will focus on updates on electronic submissions, DADI, Type II validation Team and Assessment Report revamp project. Information and discussion to be held on Regulatory Reliance, Pre-submission meetings, Network sustainability on ePI and the Raw Data Pilot.