Seventh meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine
EventHumanRegulatory and procedural guidance
- The original event time is:
- Wednesday, December 1, 2021 - 13:00 - 17:00 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
This is the seventh 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.
The meeting focus is on the repurposing pilot from EMA, the Working Parties Project implementation, the use of master data and IDMP implementation, an update on the European Commission's pilot on intent to launch orphan and oncology medicinal products, the measures taken to help the EU regulatory network cope with increased workload, and how industry can support us.
Discussions also include changes to pre-submission meeting activities and the derogation of the Irish language as an official EU language in January 2022.