Reinforcing patient safety in Europe
Date:
14/06/2011 to 15/06/2011
Location:
Zagreb, Croatia
The conference is supported by the European Commission, as part of the preparation for the enlargement process and organised by the European Medicines Agency in collaboration with the Croatian Agency for Medicinal Products and Medicinal Devices, HALMED, under the auspices of the President of the Republic of Croatia and Croatian Ministry of Health and Social Welfare.
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Agenda - Reinforcing patient safety in Europe - Conference programme (PDF/294.16 KB)
Draft
First published: 27/04/2011
Last updated: 23/06/2011
EMA/172829/2011 -
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Reinforcing patient safety in Europe - List of participants (PDF/199.12 KB)
First published: 23/06/2011
Last updated: 23/06/2011
EMA/370985/2011 Rev 1 -
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Reinforcing patient safety in Europe - Flyer (PDF/154.94 KB)
First published: 27/04/2011
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Presentation - Accession preparation: The legal framework (PDF/385.03 KB)
First published: 23/06/2011
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Presentation - Accession Preparation: Situation in Croatia (PDF/2.43 MB)
First published: 23/06/2011
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Presentation - Perspectives from a new Member State (PDF/1.32 MB)
First published: 23/06/2011
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Presentation - Accession preparation - Phasing-in (PDF/268.52 KB)
First published: 23/06/2011
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Presentation - Accession preparation II- Preparing for dossiers evaluation (PDF/2.88 MB)
First published: 23/06/2011
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Presentation - Adapting to Community referrals (PDF/118.57 KB)
First published: 23/06/2011
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Presentation - Non-clinical Assessment Requirements (PDF/267.26 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Non-clinical Assessment Requirements - Perspectives from a Member State (PDF/348.95 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - The Variations Regulation (EC) No 1234/2008: The legal framework after the revision (PDF/113.82 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - New Variations Regulation – “Quality Related Changes” (PDF/740.24 KB)
First published: 23/06/2011
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Presentation - Generics in the Centralised Procedure (PDF/222.58 KB)
First published: 23/06/2011
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Presentation - Interchangeability of generics (PDF/119.62 KB)
First published: 23/06/2011
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Presentation - Generics/Non prescription medicines - Non-prescription switching (PDF/1.12 MB)
First published: 23/06/2011
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Presentation - Electronic submissions in the EU (PDF/1.05 MB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Benefit- Risk assessment and communication (PDF/66.06 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Risk minimisation (PDF/365.9 KB)
First published: 23/06/2011
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Presentation - Product information management (PDF/411.55 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Product information management - Annex: Example label (PDF/33.81 KB)
First published: 23/06/2011
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Presentation - Product information management - Annex: Example package leaflet (PDF/85.56 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Product information management - Annex: Example SmPC (PDF/165.04 KB)
First published: 23/06/2011
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Presentation - User test (PDF/342.34 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - The new Pharmacovigilance legislation: an EMA perspective (PDF/433.5 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - The New PV Legislation Perspective from a Member State (PDF/153.67 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Crisis management (PDF/473.33 KB)
First published: 23/06/2011
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Presentation - Crisis management – Case studies (PDF/1.17 MB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Risk management for vaccines (PDF/958.2 KB)
First published: 23/06/2011
Last updated: 23/06/2011