Second stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date:
17/06/2011
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. Invitation only.
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Agenda - Second stakeholders forum on the implementation of the new pharmacovigilance legislation (PDF/78.25 KB)
Draft
First published: 10/06/2011
Last updated: 24/06/2011
EMA/366836/2011 -
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Report on the second stakeholder forum on the implementation of the new pharmacovigilance legislation (PDF/71.11 KB)
First published: 24/06/2011
Last updated: 24/06/2011
EMA/486912/2011 -
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List of participants - Second stakeholders forum on the implementation of the new pharmacovigilance legislation (PDF/178.04 KB)
First published: 24/06/2011
Last updated: 24/06/2011
EMA/451672/2011 -
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Presentation - The new pharmacovigilance legislation and implementation planning (PDF/168.24 KB)
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Presentation - New pharmacovigilance legislation and implementing measures – Minimum requirements for quality systems (marleting authorisation holder, European Medicines Agency, national competent authority), minimum req... (PDF/345.14 KB)
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Presentation - The Pharmacovigilance Risk Assessment Committee (PDF/208.35 KB)
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Presentation - Experience from patient observer in Pharmacovigilance Working Party (PDF/22.14 KB)
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Presentation - Public hearings (PDF/58.9 KB)
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Presentation - Public hearings (PDF/43.22 KB)
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Presentation - Evaluation of patient reporting to the Yellow Card System (PDF/88.92 KB)
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Last updated: 24/06/2011 -
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Presentation - European Union experiences with patient reporting (PDF/196.51 KB)
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Last updated: 24/06/2011 -
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Presentation - Yellow Card reporting – Engaging with patients (PDF/2.43 MB)
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Presentation - Direct patient reporting (PDF/417.73 KB)
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Last updated: 24/06/2011 -
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Presentation - Direct patient reporting: the Dutch case (PDF/1.15 MB)
First published: 24/06/2011
Last updated: 24/06/2011 -
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Presentation - Electronic submission of medicinal product information by marketing authorisation holders – Regulation (EC) No 726/2004, Article 57(2), 2nd subparagraph (PDF/150.35 KB)
First published: 24/06/2011
Last updated: 24/06/2011 -
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Presentation - EudraVigilance: New developments and access to EudraVigilance data (PDF/259.04 KB)
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Presentation - Patients’ organisations' use of EudraVigilance (PDF/107.27 KB)
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Presentation - EudraVigilance: Expectations of pharmacists (PDF/633.89 KB)
First published: 24/06/2011
Last updated: 24/06/2011 -
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Presentation - Combined industry view on EudraVigilance developments and access (PDF/22.9 KB)
First published: 24/06/2011
Last updated: 24/06/2011