Second industry stakeholder platform on the operation of the centralised procedure for human medicinal products

Date: 09/11/2015
Location: European Medicines Agency, London, UK
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. At the second meeting, the detailed report on the survey on post-authorisation procedures is discussed. Furthermore, specific aspects of variation management for risk management plan updates, experience with the review of mock-ups and specimens as well as a progress report on the revision of guidelines on early access tools is addressed. Registration by invitation only.

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