Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation
Date:
25/05/2012
Location:
European Medicines Agency, London, UK
The 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.
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Agenda – Fifth stakeholders forum on the implementation of the new pharmacovigilance legislation (PDF/113.75 KB)
First published: 24/05/2012
Last updated: 30/05/2012
EMA/284201/2012 -
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List of participants - Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation, 25 May 2012 (PDF/121.09 KB)
First published: 30/05/2012
Last updated: 30/05/2012
EMA/289380/2012 -
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Presentation - Pharmacovigilance in European Union: where have we come from? (PDF/3.86 MB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Implementation of the new pharmacovigilance legislation: planning and processes (PDF/1.49 MB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Implementation of the pharmacovigilance legislation (PDF/98.92 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Good pharmacovigilance practices: Key themes from the public consultation and next steps (PDF/1.19 MB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Session on identification and traceability of biological products (PDF/906.26 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Traceability of biopharmaceuticals in spontaneous reporting systems (PDF/3.95 MB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Identification and traceability of biological products: European Generic Medicines Association views (PDF/852.79 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Identification and traceability of biological products (PDF/606.45 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - New pharmacovigilance legislation: Questions and answers on practical transitional measures (PDF/490.36 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Summaries of risk management plan (PDF/327.02 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - The PRAC in PRACtice (PDF/225.59 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Current status and update of the Article 57(2) implementation (PDF/447.14 KB)
First published: 30/05/2012
Last updated: 30/05/2012 -
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Presentation - Impact on the product information of the additional monitoring of medicines (PDF/905.13 KB)
First published: 30/05/2012
Last updated: 30/05/2012