Erfaringer med Lgemiddelstyrelsen og GCP Rune Dueholm Bech

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

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

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

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

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

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

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

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

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 Orthopaedic Research Unit - Department of Orthopaedics and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark DENMARK - www. sdu. dk/ki/ortopaedkirurgi

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

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

De offentlige GCP-enheder GCP-enheden ved Århus Universitetshospital Lokalkontor på Aalborg Sygehus Region Nordjylland Region Midtjylland Ca. 10 ÅV Københavns Universitetshospitals 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 Orthopaedic Research Unit - Department of Orthopaedics and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark DENMARK - www. sdu. dk/ki/ortopaedkirurgi

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

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

Introduction – Materials and Methods – Results – Discussion - Conclusion Ansøgning • EMA (European Medicines Agency) • Eudra. CT (Ansøgningsformular) 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 • Gebyr Orthopaedic Research Unit - Department of Orthopaedics and Traumatology Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark Odense University Hospital Institute of DENMARK Clinical Research – University of Southern Denmark – www. sdu. dk/ki/orto - www. sdu. dk/ki/ortopaedkirurgi

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

GCP? Great Complicated Paperwork? ? Good Clinical Practice (Good Clinical Trial/Research Practice) God Klinisk Praksis (God Klinisk Forsøgs Praksis) Orthopaedic Research Unit - Department of Orthopaedics and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark DENMARK - www. sdu. dk/ki/ortopaedkirurgi 17

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

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

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

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 - Department of Orthopaedics and Traumatology Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark Odense University Hospital Institute of DENMARK Clinical Research – University of Southern Denmark – www. sdu. dk/ki/orto - www. sdu. dk/ki/ortopaedkirurgi

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 - Department of Orthopaedics and Traumatology Research Unit – Dept. of Orthopaedic Surgery and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark Odense University Hospital Institute of DENMARK Clinical Research – University of Southern Denmark – www. sdu. dk/ki/orto - www. sdu. dk/ki/ortopaedkirurgi

GCP-enheden ved OUH Afdeling for Klinisk Biokemi og Farmakologi GCP-enheden Odense Universitetshospital J. B. Winsløws Vej 19, 2. sal 5000 Odense C Tlf: 6550 3053 (Tanja Bidstrup) Funktionsleder: Charlotte Calov Fælles hjemmeside for GCP-enhederne i DK: www. gcp-enhed. dk Orthopaedic Research Unit - Department of Orthopaedics and Traumatology Odense University Hospital - Clinical Institute – University of Southern Denmark DENMARK - www. sdu. dk/ki/ortopaedkirurgi