Third industry stakeholder platform on the operation of the centralised procedure for human medicina
The European Medicines Agency (EMA) is hosting the third meeting of its industry stakeholder platform on the operation of the centralised procedure, which was established in April 2015. The objective of this series of semi-annual meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The third meeting will address management of accelerated assessment, pre-submission dialogue, improvements in the post-authorisation management as well as first experience with requests for PRIME.
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