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

• Date:
  Sexta, 17 Junho 2011, All day
• Localização:
  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

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

Reference Number: EMA/486912/2011

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

Reference Number: EMA/451672/2011

Presentation - The new pharmacovigilance legislation and implementation planning

Presentation - New pharmacovigilance legislation and implementing measures – Minimum requirements for quality systems (marleting authorisation holder, European Medicines Agency, national competent authority), minimum req...

Presentation - The Pharmacovigilance Risk Assessment Committee

Presentation - Experience from patient observer in Pharmacovigilance Working Party

Presentation - Public hearings

Presentation - Public hearings

Presentation - Evaluation of patient reporting to the Yellow Card System

Presentation - European Union experiences with patient reporting

Presentation - Yellow Card reporting – Engaging with patients

Presentation - Direct patient reporting

Presentation - Direct patient reporting: the Dutch case

Presentation - Electronic submission of medicinal product information by marketing authorisation holders – Regulation (EC) No 726/2004, Article 57(2), 2nd subparagraph

Presentation - EudraVigilance: New developments and access to EudraVigilance data

Presentation - Patients’ organisations' use of EudraVigilance

Presentation - EudraVigilance: Expectations of pharmacists

Presentation - Combined industry view on EudraVigilance developments and access

Multimedia