Industry stakeholder platform on the operation of the centralised procedure
Date:
24/04/2015
Location:
European Medicines Agency, London, UK
This is the first event in a series of upcoming, semi-annual meetings between regulators and representatives of industry stakeholder organisations. It aims 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 meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the interface in interactions with the applicant during evaluation procedures as well as the management of variations. Registration by invitation only. Registration closed.
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Highlights from the European Medicines Agency industry platform meeting held on 24 April 2015 on the operation of the centralised procedure (PDF/115.91 KB)
First published: 29/05/2015
Last updated: 29/05/2015
EMA/290883/2015 -
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Agenda - Industry stakeholder platform on the operation of the centralised procedure (PDF/93.73 KB)
First published: 29/04/2015
Last updated: 29/04/2015
EMA/207894/2015 -
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Presentation - Status update of changes to the operations in the centralised procedure (Evdokia Korakianiti) (PDF/141.19 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - European Medicines Agency product team and applicant/marketing authorisation holder interaction (Michael Berntgen) (PDF/345.72 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - Perspective of EPL and PM regarding interactions with applicants (Pavel Balabanov, Leonor Enes, Viktor Vlcek) (PDF/110.47 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - Procedure management of variations (Alberto Ganan, Iordanis Gravanis) (PDF/186.38 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - New practice for the management of clarification meetings (Pavel Balabanov) (PDF/178.37 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - European Medicines Agency survey on "Centralised post-marketing authorisation procedures" 2015 (Marie-Helene Pinheiro) (PDF/607.73 KB)
First published: 29/04/2015
Last updated: 29/04/2015 -
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Presentation - Raise the game (Enrica Alteri) (PDF/38.39 KB)
First published: 29/04/2015
Last updated: 29/04/2015