First stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date:
15/04/2011
Location:
London, UK
The objective of the stakeholder forum is to raise awareness of the requirements of the new 2010 pharmacovigilance legislation and promote the exchange of ideas, concerns and opinions. Participants will discuss EMA / Member States technical contribution to draft European Commission implementing measures.
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Agenda - First Stakeholders forum on the implementation of the new Pharmacovigilance legislation (PDF/85.58 KB)
First published: 19/04/2011
Last updated: 19/04/2011
EMA/280084/2011 -
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List of participants - First stakeholder forum on the implementation of the new pharmacovigilance legislation (PDF/119.23 KB)
First published: 19/04/2011
Last updated: 19/04/2011
EMA/278009/2011 -
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Presentation - New EU Pharmacovigilance Legislation to promote and protect public health
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Presentation - Pharmacovigilance – Impact on patients
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Presentation - Pharmacovigilance: Reporting of Adverse Reactions?
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Presentation - Pharmacovigilance: Perspective of pharmacists
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Presentation - Implementation of Pharmacovigilance Legislation: Industry (Innovative) Perspective
First published: 19/04/2011
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Presentation - EGA View on the New Legislation
First published: 19/04/2011
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Presentation - Contribution from the Association of the European Self-Medication Industry (AESGP)
First published: 19/04/2011
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Presentation - Implementation of the New Pharmacovigilance Legislation
First published: 19/04/2011
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Presentation - Key concepts on communication and transparency
First published: 19/04/2011
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Presentation - Structure of Good Pharmacovigilance Practice GVP
First published: 19/04/2011
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Presentation - Quality Management System for the performance of pharmacovigilance activities
First published: 19/04/2011
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Presentation - Internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities
First published: 19/04/2011
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Presentation - EC Implementing Measure - Minimum requirements for the monitoring of data in the EudraVigilance database to determine whether there are new risks or whether risks have changed
First published: 19/04/2011
Last updated: 19/04/2011 -
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Presentation - Format and content of electronic periodic safety update reports
First published: 19/04/2011
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Presentation - Implementation of Risk Management Systems
First published: 19/04/2011
Last updated: 19/04/2011 -
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Presentation - EC Implementing Measure - The format of protocols, abstracts and final study reports for the non-interventional post- authorisation safety studies
First published: 19/04/2011
Last updated: 19/04/2011