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EMA Events
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EMA is hosting the seventh industry stakeholder platform on the operation of the centralised procedure for human medicines on 1 December, from 13:00 to 17:00.
This will be 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.
This meeting will focus 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 will also include changes to pre-submission meeting activities and the derogation of the Irish language as an official EU language in January 2022.
Sumber : https://www.ema.europa.eu
This will be 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.
This meeting will focus 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 will also include changes to pre-submission meeting activities and the derogation of the Irish language as an official EU language in January 2022.
Sumber : https://www.ema.europa.eu