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

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Contact point:

Jolanta Palepsaitiene
jolanta.palepsaitiene@ema.europa.eu