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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Highlights from the second industry stakeholder platform on the operation of the centralised procedure for human medicinal products held on 9 November 2015 (PDF/123.28 KB)
First published: 25/02/2016
Last updated: 25/02/2016
EMA/5702/2016 -
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Agenda - Second industry stakeholder platform on the operation of the centralised procedure for human medicinal products (PDF/99.44 KB)
First published: 12/11/2015
Last updated: 12/11/2015
EMA/633298/2015 -
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Presentation - Optimising early access tools: revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation (Tomas Salmonson) (PDF/488 KB)
First published: 12/11/2015
Last updated: 12/11/2015 -
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Presentation - Mock ups and specimen review: labelling review and Standards Office (Monica Prizzi) (PDF/1.37 MB)
First published: 12/11/2015
Last updated: 12/11/2015 -
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Presentation - Management of the risk management plan for centrally authorised products in post-authorisation: European Medicines Agency perspective (Iordanis Gravanis) (PDF/166.26 KB)
First published: 12/11/2015
Last updated: 12/11/2015 -
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Presentation - Overview of recent changes in the centralised procedure (Michael Berntgen) (PDF/987.37 KB)
First published: 12/11/2015
Last updated: 12/11/2015 -
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Presentation - European Medicines Agency survey on post-authorisation procedures (Marie-Hà©là¨ne Pinheiro, Alberto Ganan-Jimenez) (PDF/584.77 KB)
First published: 12/11/2015
Last updated: 12/11/2015