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

Event

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Date

petak, 17 lipnja 2011, Cijeli dan

Lokacija

European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Second stakeholders forum on the implementation of the new pharmacovigilance legislation

Draft Reference Number: EMA/366836/2011

English (EN) (78.25 KB - PDF)

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Report on the second stakeholder forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/486912/2011

English (EN) (71.11 KB - PDF)

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List of participants - Second stakeholders forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/451672/2011

English (EN) (178.04 KB - PDF)

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Presentation - The new pharmacovigilance legislation and implementation planning

English (EN) (168.24 KB - PDF)

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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...

English (EN) (345.14 KB - PDF)

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Presentation - The Pharmacovigilance Risk Assessment Committee

English (EN) (208.35 KB - PDF)

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Presentation - Experience from patient observer in Pharmacovigilance Working Party

English (EN) (22.14 KB - PDF)

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Presentation - Public hearings

English (EN) (58.9 KB - PDF)

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Presentation - Public hearings

English (EN) (43.22 KB - PDF)

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Presentation - Evaluation of patient reporting to the Yellow Card System

English (EN) (88.92 KB - PDF)

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Presentation - European Union experiences with patient reporting

English (EN) (196.51 KB - PDF)

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Presentation - Yellow Card reporting – Engaging with patients

English (EN) (2.43 MB - PDF)

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Presentation - Direct patient reporting

English (EN) (417.73 KB - PDF)

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Presentation - Direct patient reporting: the Dutch case

English (EN) (1.15 MB - PDF)

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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

English (EN) (150.35 KB - PDF)

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Presentation - EudraVigilance: New developments and access to EudraVigilance data

English (EN) (259.04 KB - PDF)

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Presentation - Patients’ organisations' use of EudraVigilance

English (EN) (107.27 KB - PDF)

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Presentation - EudraVigilance: Expectations of pharmacists

English (EN) (633.89 KB - PDF)

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Presentation - Combined industry view on EudraVigilance developments and access

English (EN) (22.9 KB - PDF)

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