First stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation

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TitleFirst stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date15/04/2011 - 15/04/2011
LocationLondon, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - First Stakeholders forum on the implementation of the new Pharmacovigilance legislation (English only) 19/04/2011  
List of participants - First stakeholder forum on the implementation of the new pharmacovigilance legislation (English only) 19/04/2011  
Presentation - New EU Pharmacovigilance Legislation to promote and protect public health (English only) 19/04/2011  
Presentation - Pharmacovigilance – Impact on  patients (English only) 19/04/2011  
Presentation - Pharmacovigilance: Reporting of Adverse Reactions? (English only) 19/04/2011  
Presentation - Pharmacovigilance: Perspective of pharmacists (English only) 19/04/2011  
Presentation - Implementation of Pharmacovigilance Legislation: Industry (Innovative) Perspective (English only) 19/04/2011  
Presentation - EGA View on the New Legislation (English only) 19/04/2011  
Presentation - Contribution from the Association of the European Self-Medication Industry (AESGP) (English only) 19/04/2011  
Presentation - Implementation of the New Pharmacovigilance Legislation (English only) 19/04/2011  
Presentation - Key concepts on communication and transparency (English only) 19/04/2011  
Presentation - Structure of Good Pharmacovigilance Practice GVP (English only) 19/04/2011  
Presentation - Quality Management System for the performance of pharmacovigilance activities (English only) 19/04/2011  
Presentation - Internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities (English only) 19/04/2011  
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 (English only) 19/04/2011  
Presentation - Format and content of electronic periodic safety update reports (English only) 19/04/2011  
Presentation - Implementation of Risk Management Systems (English only) 19/04/2011  
Presentation - EC Implementing Measure - The format of protocols, abstracts and final study reports for the non-interventional post- authorisation safety studies (English only) 19/04/2011  

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Contact point:

Valerie Muldoon
valerie.muldoon@ema.europa.eu