Declan ORourke MVB FRCVS

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Pharmacovigilance Guidelines HARMONISATION LET'S
GO VICH

• Declan ORourke MVB FRCVS

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• Harmonisation - the action or process of
  harmonising
• Harmonise - to bring into agreement (two or more
  things, or one thing with another).

Oxford Dictionary
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HARMONISATION

• At EU level
• At Global level (VICH)

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HARMONISATION AT EU LEVEL
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HARMONISATION AT EU LEVEL

• Guidelines exist
• However,
• Variation in reporting levels between Member
  States
• Quality of reports - what is adequate?
• You need a series of reports to make a
  decision.
• Consistency of causality and coding.

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HARMONISATION AT EU LEVEL

• Other issues
• More dialogue required between MAH and RA
• Malicious reports, e.g. via Internet.
• How do we deal with these?
• Upgrades of VEDDRA
• Publication of PV data
• - need for transparency vs confidentiality

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HARMONISATION AT GLOBAL LEVEL
(VICH)
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HARMONISATION AT GLOBAL LEVEL
(VICH)

• Membership
• FDA, USDA, Japan MAFF
• AHI, FEDESA, Japan Industry
• Australia/New Zealand RAs plus Industry
  (Observer)

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HARMONISATION AT GLOBAL LEVEL
(VICH)

• STAGE 1
• Provide recommendations on
• Definitions - ADE, etc.
• Scope of Reports
• Timing for Submission of Reports
• Reporting Format/ Key data elements to be
  included in report (to facilitate electronic
  submission)
• GL24 - Management of Adverse Events Reports

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HARMONISATION AT GLOBAL LEVEL
(VICH)

• STAGE 2
• Develop an internationally accepted terminology
  database. (VEDDRA)
• GL30 - Controlled Lists of Terms
• STAGE 3
• Develop recommendations on causality assessment.

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HARMONISATION

• We need harmonisation to ensure a good PV system
  (increased quality)
• We have come a long way. But we still have a long
  way to go.
• Electronic submission of reports will not ensure
  harmonisation.

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HARMONISATION

• IT IS THE QUALITY OF REPORTS NOT THE QUANTITY
  THAT COUNTS

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