Allen frances dsm5 - Selling Sickness Conference 2010
Josée hansen igz
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3. Competing interests Supervision and law enforcement in the Netherlands | 7 October 2010 public health needs <–> market driven phase IV study <–> seeding trials information <–> promotion clinical support <–> gifts clinical guidelines <–> disease mongering training <–> influencing
4. The Dutch way Introductie stafmedewerkers | 27 september 2010 Minister SG DG DG DG IG Public health Health care Long term care Medical products CBG CCMO Lareb
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8. Regulators in the Netherlands Supervision and law enforcement in the Netherlands | 7 October 2010 health product Health Products (HP) Non-prescription Medicines (OTC) Prescription Only medicines (POM) Medical Devices (MD) regulator Inspection Board for the Public Promotion of Medicines (KOAG) - Minor violations of law All violations of Code of Conduct - - Code of conduct for pharmaceutical advertising (CGR) - - Minor violations of law All violations of Code of Conduct - Health care Inspectorate - Recurrent minor violations of law All major violations of law Recurrent minor violations of law All major violations of law -
9. Collaboration: how it could be done Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / CGR / KOAG Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Case closed
10. Real life: parallel tracks Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / KOAG HCI / KOAG assesses case and decides on appropriate regulator Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed Suspected violation is reported to CGR Case handled by CGR Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed All cases regarding promotion directed at health care professionals All cases regarding promotion directed at the public