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Date
Locație
EMA is hosting the 11th industry stakeholder platform on the operation of the centralised procedure for human medicines on 24th November 2023. This is 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 digitalisation on eAF for variations and implementation of IRIS for variations 61.3 and MAH transfers; on the submission predictability focus group and on issues raised during validation of variations.
Information and discussion to be held on the revised variation framework, patient engagement in centralised procedure, working parties and new ways of working and Windsor protocol implementation aspects.