Reinforcing patient safety in Europe

• 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

DraftReference Number: EMA/172829/2011

Reinforcing patient safety in Europe - List of participants

Reference Number: EMA/370985/2011 Rev 1

Reinforcing patient safety in Europe - Flyer

Presentation - Accession preparation: The legal framework

Presentation - Accession Preparation: Situation in Croatia

Presentation - Perspectives from a new Member State

Presentation - Accession preparation - Phasing-in

Presentation - Accession preparation II- Preparing for dossiers evaluation

Presentation - Adapting to Community referrals

Presentation - Non-clinical Assessment Requirements

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

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

Presentation - New Variations Regulation – “Quality Related Changes”

Presentation - Generics in the Centralised Procedure

Presentation - Interchangeability of generics

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

Presentation - Electronic submissions in the EU

Presentation - Benefit- Risk assessment and communication

Presentation - Risk minimisation

Presentation - Product information management

Presentation - Product information management - Annex: Example label

Presentation - Product information management - Annex: Example package leaflet

Presentation - Product information management - Annex: Example SmPC

Presentation - User test

Presentation - The new Pharmacovigilance legislation: an EMA perspective

Presentation - The New PV Legislation Perspective from a Member State

Presentation - Crisis management

Presentation - Crisis management – Case studies

Presentation - Risk management for vaccines