Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain

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PharmacovigilanceWorkshop27-28 May 2002
(Madrid, Spain)

• How to promote veterinary pharmacovigilance
  system?
• Is it being used appropriately?

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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

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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

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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

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Resources/Money
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