Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation

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TitleFifth stakeholder forum on the implementation of the new pharmacovigilance legislation
Date25/05/2012 - 25/05/2012
LocationEuropean Medicines Agency, London, UK
SummaryThe objectives of the meeting are to present an update to the implementation process, key feedback from recent consultations, questions and answers on the transitional period, specific considerations for biological medicines and feedback on other topics. Registration by invitation only.

All documents

Name Language First published Last updated
Agenda – Fifth stakeholders forum on the implementation of the new pharmacovigilance legislation (English only) 24/05/2012 30/05/2012
List of participants - Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation, 25 May 2012 (English only) 30/05/2012  
Presentation - Pharmacovigilance in European Union: where have we come from? (English only) 30/05/2012  
Presentation - Implementation of the new pharmacovigilance legislation: planning and processes (English only) 30/05/2012  
Presentation - Implementation of the pharmacovigilance legislation (English only) 30/05/2012  
Presentation - Good pharmacovigilance practices: Key themes from the public consultation and next steps (English only) 30/05/2012  
Presentation - Session on identification and traceability of biological products (English only) 30/05/2012  
Presentation - Traceability of biopharmaceuticals in spontaneous reporting systems (English only) 30/05/2012  
Presentation - Identification and traceability of biological products: European Generic Medicines Association views (English only) 30/05/2012  
Presentation - Identification and traceability of biological products (English only) 30/05/2012  
Presentation - New pharmacovigilance legislation: Questions and answers on practical transitional measures (English only) 30/05/2012  
Presentation - Summaries of risk management plan (English only) 30/05/2012  
Presentation - The PRAC in PRACtice (English only) 30/05/2012  
Presentation - Current status and update of the Article 57(2) implementation (English only) 30/05/2012  
Presentation - Impact on the product information of the additional monitoring of medicines (English only) 30/05/2012  

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Contact point:

Jolanta Palepsaitiene
jolanta.palepsaitiene@ema.europa.eu