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Erfaringer med Lægemiddelstyrelsen og GCP

Erfaringer med Lægemiddelstyrelsen og GCP. Rune Dueholm Bech. Orthopaedic Research Unit Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Inst. of Clinical Research – University of Southern Denmark. Tanja Bidstrup. GCP-enheden Odense Universitetshospital.

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Erfaringer med Lægemiddelstyrelsen og GCP

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  1. Erfaringer med Lægemiddelstyrelsen og GCP Rune Dueholm Bech Orthopaedic Research Unit Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Inst. of Clinical Research – University of Southern Denmark Tanja Bidstrup GCP-enheden Odense Universitetshospital www.sdu.dk/ki/orto

  2. Lov om Lægemidler § 88. Et klinisk forsøg med lægemidler må kun udføres, når Lægemiddelstyrelsen har givet tilladelse til forsøget (….) Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  3. Lægemiddelstyrelsen Spørgsmål og svar om kliniske forsøg: Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  4. Den Videnskabsetiske Komité Datatilsynet Arbejdstilsynet Offentlig tilgængelig database Lægemiddelstyrelsen Introduction– Materials and Methods – Results – Discussion - Conclusion Godkendelser Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  5. Godkendelser § 88. Forsøg med lægemidler på mennesker skal foregå i overensstemmelse med GCP (Good Clinical Practice) Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  6. Good Clinical Practice International etisk og videnskabelig kvalitetsstandard Design Udførelse Datadokumentation Afrapportering Introduction– Materials and Methods – Results – Discussion - Conclusion Emea: European Medicines Agency Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  7. Good Clinical Practice Sikre overholdelse af forsøgspersoners rettigheder og sikkerhed Sikre valide, komplette og dokumenterede data Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  8. Good Clinical Practice Vejledende retningslinier for: Forsøgsprotokol Beskyttelse af forsøgspersoner Ansvarsfordeling Datahåndtering Håndtering af testmedicin Dokumentation og arkivering Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  9. GCP-enhedernes formål GCP-enhederne er oprettet med det formål at implementere og vedligeholde et standardiseret kvalitetssikringssystem omkring kliniske lægemiddelforsøg, der skal gøre det muligt at gennemføre lokale lægeinitierede forsøg i overensstemmelse med GCP-guideline. Finansiering: Basisbevilling (Regioner (Sygehuse) og evt. Universiteter) Brugerbetaling (100 timer uden beregning) Mindre indtægter fra undervisning

  10. Good Clinical Practice Monitorering (Kvalitetskontrol) Certificeret monitor Lægemiddelindustriforeningens GCP-kursus Audit (Kvalitetssikring) Uafhængig GCP-enhed, indgår som en del af kontrakten med De Offentlige GCP-enheder Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  11. GCP-erfaring Introduction– Materials and Methods– Results – Discussion - Conclusion www.gcp-enhed.dk Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  12. De offentlige GCP-enheder GCP-enheden ved Århus Universitetshospital Lokalkontor på Aalborg Sygehus Region Nordjylland Region Midtjylland Ca.10 ÅV Københavns Universitets- hospitals GCP-enhed Region Sjælland Region Hovedstaden Ca.14 ÅV GCP-enheden ved Odense Universitetshospital Region Syddanmark Ca.7 ÅV • GCP-netværket – GCP-enhedernes samarbejde – bl.a. • Kvalitetssikrinssystemer - SOP • Monitorering af multicenterforsøg • Efteruddannelse af GCP-enhedernes personale / Vidensdeling • Kursusaktivitet • Eksterne samarbejdspartnere (LMS, VEK, Datatilsynet, EU) • Audit

  13. Introduction– Materials and Methods – Results – Discussion - Conclusion De Offentlige GCP-enheder Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  14. GCP-enheden ved OUH 100 timers gratis vejledning/monitorering Herefter kr. 400 pr. time Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  15. Ansøgning EMA (European Medicines Agency) EudraCT (Ansøgningsformular) Gebyr Introduction– Materials and Methods– Results – Discussion - Conclusion D.2.2 For situations where the IMP to be used in the CT has a MA in the MS concerned but the protocol allows that any brand of the IMP with a MA in that MS be administered to the trial subjects and it is not possible to clearly identify the IMP(s) in advance of the trial start Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  16. Ansøgning Introduction– Materials and Methods – Results – Discussion - Conclusion Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  17. GCP? Great Complicated Paperwork?? Good Clinical Practice (Good Clinical Trial/Research Practice) God Klinisk Praksis (God Klinisk Forsøgs Praksis) 17

  18. Introduction– Materials and Methods – Results – Discussion - Conclusion Druknedød for klinisk forskning? Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  19. Introduction– Materials and Methods – Results – Discussion - Conclusion Druknedød for klinisk forskning? Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  20. Introduction– Materials and Methods – Results – Discussion - Conclusion Status • Regulation via europæisk lovgivning • Rigid anmeldelsesprocedure via EudraCT • God service ved henvendelse til Lægemiddelstyrelsen • GCP-krav er omstændige, men også ”blåstempling” af projekt • GCP-enhed er serviceorgan Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  21. Introduction– Materials and Methods – Results – Discussion - Conclusion Kommet for at blive • Tiltagende krav om dokumentation og kvalitetssikring • Medicinsk udstyr • Højt profilerede tidsskrifter Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  22. Introduction– Materials and Methods – Results – Discussion - Conclusion Erfaringer • Kontakt GCP-enheden tidligt i forløbet • Betragt GCP-enheden som serviceorgan • Brug protokolskabeloner • Indsend først protokol til Lægemiddelstyrelsen og Videnskabsetisk Komité efter GCP-enheden har gennemgået og givet kommentarer Orthopaedic Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital Institute of Clinical Research – University of Southern Denmark – www.sdu.dk/ki/orto

  23. GCP-enheden ved OUH Afdeling for Klinisk Biokemi og FarmakologiGCP-enhedenOdense UniversitetshospitalJ. B. Winsløws Vej 19, 2. sal5000 Odense C Tlf: 6550 3053 (Tanja Bidstrup) Funktionsleder: Charlotte Calov Fælles hjemmeside for GCP-enhederne i DK: www.gcp-enhed.dk

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