Tenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
EventRegulatory and procedural guidance
- The original event time is:
- Tuesday, June 27, 2023 - 09:30 - 13:30 Amsterdam time (CEST)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
EMA is hosting the 10th industry stakeholder platform on the operation of the centralised procedure for human medicines on 27th June 2023. This will be the tenth 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 policy 0070, RMP publication, on submission predictability focus groups and on CHMP AR Revamp project. Information and discussion to be held on the expansion of OPEN framework to other type of products, Regulatory Reliance, patient engagement from drug development to authorisation, ePI and Scientific Committees organisational aspects post EMA business continuity plan (BCP).