Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain - PowerPoint PPT Presentation

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Title:

Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain

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1. Pharmacovigilance. Workshop. 27-28 May 2002 (Madrid, Spain) ... Increase awareness amongst partners. Partners MAHs, CAs, vets, owners/others ... – PowerPoint PPT presentation

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Title: Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain


1
PharmacovigilanceWorkshop27-28 May 2002
(Madrid, Spain)
  • How to promote veterinary pharmacovigilance
    system?
  • Is it being used appropriately?

2
Increase awareness amongst partners
  • Partners MAHs, CAs, vets, owners/others
  • Promotion to all key groups
  • Informing via user guide
  • - Mail shots, advertising, education
  • Education and training
  • Publication of results confidentiality
  • Feedback to individual reporters

3
Increased reporting
  • Legal requirement?
  • Electronic reporting
  • Harmonised form/information
  • Feedback to reporters
  • publication of PKV/Phv data
  • to individual reporters
  • SPC/data sheet changes

4
Improved data quality
  • Investigation
  • - MAHs, PKV centres, other
  • Direct reporting to CAs
  • - MAH informed ASAP
  • Completeness of form/reports
  • - validation, chase-up
  • Consistency of causality coding
  • Use of standard dictionaries eg VEDDRA

5
Improved effectiveness of PKV
  • Publishing of results
  • Electronic storage and analysis of PSURs
  • Increased dialogue between CAs and MAHs
  • - involvement of MAHs in specific Phv WP
    discussions

6
Resources/Money
7
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