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

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TitleSecond stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date17/06/2011 - 17/06/2011
LocationLondon, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Second stakeholders forum on the implementation of the new pharmacovigilance legislation (English only) 2011-06-10 2011-06-24
Report on the second stakeholder forum on the implementation of the new pharmacovigilance legislation (English only) 2011-06-24  
List of participants - Second stakeholders forum on the implementation of the new pharmacovigilance legislation (English only) 2011-06-24  
Presentation - The new pharmacovigilance legislation and implementation planning (English only) 2011-06-24  
Presentation - New pharmacovigilance legislation and implementing measures – Minimum requirements for quality systems (marleting authorisation holder, European Medicines Agency, national competent authority), minimum requirements for Pharmacovigilance System Master File (English only) 2011-06-24  
Presentation - The Pharmacovigilance Risk Assessment Committee (English only) 2011-06-24  
Presentation - Experience from patient observer in Pharmacovigilance Working Party (English only) 2011-06-24  
Presentation - Public hearings (English only) 2011-06-24  
Presentation - Public hearings (English only) 2011-06-24  
Presentation - Evaluation of patient reporting to the Yellow Card System (English only) 2011-06-24  
Presentation - European Union experiences with patient reporting (English only) 2011-06-24  
Presentation - Yellow Card reporting – Engaging with patients (English only) 2011-06-24  
Presentation - Direct patient reporting (English only) 2011-06-24  
Presentation - Direct patient reporting: the Dutch case (English only) 2011-06-24  
Presentation - Electronic submission of medicinal product information by marketing authorisation holders – Regulation (EC) No 726/2004, Article 57(2), 2nd subparagraph (English only) 2011-06-24  
Presentation - EudraVigilance: New developments and access to EudraVigilance data (English only) 2011-06-24  
Presentation - Patients’ organisations' use of EudraVigilance (English only) 2011-06-24  
Presentation - EudraVigilance: Expectations of pharmacists (English only) 2011-06-24  
Presentation - Combined industry view on EudraVigilance developments and access (English only) 2011-06-24  

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