Reinforcing patient safety in Europe

Event

Date: Tuesday, 14 June 2011, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Reinforcing patient safety in Europe - Conference programme

Draft Reference Number: EMA/172829/2011

English (EN) (294.16 KB - PDF)

First published: 27/04/2011 Last updated: 23/06/2011

Reinforcing patient safety in Europe - List of participants

Reference Number: EMA/370985/2011 Rev 1

English (EN) (199.12 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Reinforcing patient safety in Europe - Flyer

English (EN) (154.94 KB - PDF)

First published: 27/04/2011 Last updated: 27/04/2011

Presentation - Accession preparation: The legal framework

English (EN) (385.03 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Accession Preparation: Situation in Croatia

English (EN) (2.43 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Perspectives from a new Member State

English (EN) (1.32 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Accession preparation - Phasing-in

English (EN) (268.52 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Accession preparation II- Preparing for dossiers evaluation

English (EN) (2.88 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Adapting to Community referrals

English (EN) (118.57 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Non-clinical Assessment Requirements

English (EN) (267.26 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Non-clinical Assessment Requirements - Perspectives from a Member State

English (EN) (348.95 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - The Variations Regulation (EC) No 1234/2008: The legal framework after the revision

English (EN) (113.82 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - New Variations Regulation – “Quality Related Changes”

English (EN) (740.24 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Generics in the Centralised Procedure

English (EN) (222.58 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Interchangeability of generics

English (EN) (119.62 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Generics/Non prescription medicines - Non-prescription switching

English (EN) (1.12 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Electronic submissions in the EU

English (EN) (1.05 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Benefit- Risk assessment and communication

English (EN) (66.06 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Risk minimisation

English (EN) (365.9 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Product information management

English (EN) (411.55 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Product information management - Annex: Example label

English (EN) (33.81 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Product information management - Annex: Example package leaflet

English (EN) (85.56 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Product information management - Annex: Example SmPC

English (EN) (165.04 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - User test

English (EN) (342.34 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - The new Pharmacovigilance legislation: an EMA perspective

English (EN) (433.5 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - The New PV Legislation Perspective from a Member State

English (EN) (153.67 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Crisis management

English (EN) (473.33 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Crisis management – Case studies

English (EN) (1.17 MB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011

Presentation - Risk management for vaccines

English (EN) (958.2 KB - PDF)

First published: 23/06/2011 Last updated: 23/06/2011