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

Event

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Date

Friday, 17 June 2011, All day

Post

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)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - The new pharmacovigilance legislation and implementation planning

English (EN) (168.24 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - The Pharmacovigilance Risk Assessment Committee

English (EN) (208.35 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Experience from patient observer in Pharmacovigilance Working Party

English (EN) (22.14 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Public hearings

English (EN) (58.9 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Public hearings

English (EN) (43.22 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Evaluation of patient reporting to the Yellow Card System

English (EN) (88.92 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - European Union experiences with patient reporting

English (EN) (196.51 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Yellow Card reporting – Engaging with patients

English (EN) (2.43 MB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Direct patient reporting

English (EN) (417.73 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
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Presentation - Direct patient reporting: the Dutch case

English (EN) (1.15 MB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - EudraVigilance: New developments and access to EudraVigilance data

English (EN) (259.04 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Patients’ organisations' use of EudraVigilance

English (EN) (107.27 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
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Presentation - EudraVigilance: Expectations of pharmacists

English (EN) (633.89 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Presentation - Combined industry view on EudraVigilance developments and access

English (EN) (22.9 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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