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Centres of Excellence in Pharmacoepidemiology and Pharmacovigilance

Centres of Excellence in Pharmacoepidemiology and Pharmacovigilance. 莫尔 教授 法国波尔多第二大学. Needs in Pharmacoepi. Regulators Assess drug alerts rapidly Find expertise Industry Response to regulatory requirements Quality/transparency requirements. Regulatory requirements. Drug safety issues

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Centres of Excellence in Pharmacoepidemiology and Pharmacovigilance

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  1. Centres of Excellence in Pharmacoepidemiology and Pharmacovigilance 莫尔 教授 法国波尔多第二大学

  2. Needs in Pharmacoepi • Regulators • Assess drug alerts rapidly • Find expertise • Industry • Response to regulatory requirements • Quality/transparency requirements

  3. Regulatory requirements • Drug safety issues • Risk management programs • Risk minimization activities • Drug activity • Comparative effectiveness • Cost - effectiveness

  4. Post-marketing assessment • Drug utilization studies • Drug safety studies • Effectiveness • Field studies • Database studies

  5. 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)

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

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

  8. 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

  9. ENCEPP Checklist • Must be checked and transmitted before study begins

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

  11. 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

  12. Encepp guide on methodological standards for public consultation

  13. 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?

  14. 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?

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

  16. Where whall we start?

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