Centres of Excellence in Pharmacoepidemiology and Pharmacovigilance

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Centres of Excellence in Pharmacoepidemiology and
Pharmacovigilance

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Needs in Pharmacoepi

• Regulators
• Assess drug alerts rapidly
• Find expertise
• Industry
• Response to regulatory requirements
• Quality/transparency requirements

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Regulatory requirements

• Drug safety issues
• Risk management programs
• Risk minimization activities
• Drug activity
• Comparative effectiveness
• Cost - effectiveness

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Post-marketing assessment

• Drug utilization studies
• Drug safety studies
• Effectiveness
• Field studies
• Database studies

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ENCEPP centres

• European network of centres of excellence in
  pharmacovigilance and pharmacoepidemiology
• Self-designated centres
• Academic research centres (ARO)
• Contract research organisations (CRO)
• Non-profit CRO (PRO)

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ENCEPP centres

• With access to databases
• GPRD, THIN (UK)
• IPCI (NL)
• Italian regional groups (Italy)
• Experience doing field studies
• Bordeaux
• DSRU

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ENCEPP

• www.encepp.eu
• Database of resources
• Centres
• Databases
• Database of studies
• ENCEPP Seal

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ENCEPP Code of Conduct

• Mentioned in study contract
• Contract with study sponsor
• Property of results
• ENCEPP CC
• Registration of study in ENCEPP database
• Protocol provided (made public later)
• Results made public

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ENCEPP Checklist

• Must be checked and transmitted before study
  begins

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ENCEPP Studies

• 50 Centres in Europe
• 6 studies in database
• 3 studies registred as of date with ENCEPP Seal

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Encepp Studies

• Long-term outcomes and adverse events of therapy
  with inhaled corticosteroids, long-acting
  beta-2-agonists and anticholinergic drugs in
  hospitalised patients with Chronic Obstructive
  Pulmonary Disease (COPD) - a cohort study based
  on health information systems in three Italian
  regions.
• International Active Surveillance study - Folate
  and Oral Contraceptive Utilization Study
• International Active Surveillance Study of Women
  Taking Dienogest for Endometriosis Visanne
  Post-approval Observational Study

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Encepp guide on methodological standards

• for public consultation

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ENCEPP centres outside Europe?

• Still under discussion
• Participation to multicentre studies including
  Europe
• Encepp seal for studies done outside Europe for
  submission to EMA
• Encepp seal for studies independent of EMA?

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ANCEPP?

• Asian Network of Centres of Excellence in
  Pharmacoepi and pharmacovigilance
• Using same basic principles
• Code of conduct
• Transparency
• Publicly registred studies
• Publication of results
• Registration/database?

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ANCEPP?

• Where would AMA (Asian Mediciens Agency) be?
• HK SAR
• PRC mainland
• Taiwan
• Korea
• Singapore
• Japan
• Elsewhere?

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Where whall we start?