Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain

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Pharmacovigilance Workshop27-28 May 2002
(Madrid, Spain)

• Breakout Session 3
• How to promote pharmacovigilance?
• Chair T. Kamphuis
• Rapporteur F. Nind

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They answered as they took their fees There is
no cure for this disease Hilaire Belloc
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1. What ideas do we want to sell?

• Define Adverse Events
• Detrimental action not in line with the expected
  therapeutic effect.
• Expected and unexpected.
• Does the event relate to the treatment
• Time frame.
• Benefits
• Leads to refinement of medicines.
• Money!

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What ideas do we want to sell? (continued)

• Ethical responsibilities to report.
• Exchange of information
• Pharmaceutical companies.
• Statutory authorities.
• Positive
• Scientific.
• Administrative.

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What ideas do we want to sell? (continued)

• Targeted to the audience
• Quality assurance.
• Protection of the animals.
• Protection of the environment.
• Proportionate.

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2. Target groups

• Veterinary practitioners
• GVP.
• Ethical code.
• Students.
• Teachers.
• Pharmaceutical companies.
• Animal owners.
• European approach
• Local modifications.

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3. Expectations from these groups? How to fulfil?

• Help in investigation.
• Two way communication.
• Continue reinforcement.

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4. Education how to proceed?

• Train the trainers
• Faculties
• Students.
• Teachers.
• Vet organisations.
• Farmer organisations.
• Sales forces.
• Material required

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5. Success stories

• Transparency.
• Together.
• Speed.

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I treated it, God cured it. James Spreull.