Good Clinical Practice effective conducting of clinical trials; 3 credits

Transkript

1 PRELIMINARY PROGRAMME ; 3 credits MH/LLÅ/GJ/ EL/ Moderator MH ES/NÖ incl. coffee Course introduction, aims of the course. Presentation of participants and faculty. Introduction to GCP scenario and brainstorming of a clinical trial. History and legislation of clinical trials. Development of new drugs; different phases in drug development LUNCH Tutorial group The Declaration of Helsinki - impact on a clinical trial. Discussion in plenum Coffee Examination task; information and group task ES, EL mm Karljohan, plan 10, LLÅ Karljohan, plan 10, LLÅ Karljohan, plan 10, LLÅ/MH/ES Karljohan, plan 10, O- huset Förmaket, Sinus, HCadmin, plan 11, Huvudblocket, US Karljohan, plan 10, O- huset, Förmaket, Sinus, HC-admin, plan 11, Huvudblocket, US 1

2 Application to ethics committee, informed consent. Gunilla Sydsjö Rönnen lärosal, ingång 65 eller 64, plan 10, Hälsouniversitet Moderator ES Coffee Group Task - Patient information informed consent. Ethical committee application LUNCH Rönnen lärosal, ingång 65 eller64, plan 10, Hälsouniversitet, Bersån Ingång 13, plan 12, Kvadraten, plan 10, Huvudblocket incl. coffee Group Task continued Rönnen lärosal, ingång 65 eller64, plan 10, Hälsouniversitet, Bersån Ingång 13, plan 12, Kvadraten, plan 10, Huvudblocket Discussion - Patient information informed consent. Ethical committee application. In plenum Rönnen lärosal, ingång 65 eller 64, plan 10, Hälsouniversitet 2

3 Group task continued preparations/ Moderator ES questions to MPA Coffee Medical Product Agency role, rules and application. Björn Zethelius, Katarina Thor Fårtickan, Kantarellen/ Karljohan, LUNCH Inspections and audits in clinical trials incl. coffee Group Task Medical Product Agency Katarina Thor, Björn Zethelius Karljohan, Fårtickan, Kantarellen/ 3

4 Methodology- design, planning and MH/ES Karljohan, Moderator MH reporting of a clinical trial Coffee The responsibility of the sponsor, PKJ sponsor Karljohan, investigator and the head (huvudmannen) including protocol, CRF and informed consent. ES investigator EW head LUNCH Research nurse - role and LLÅ/GJ/EL Karljohan, responsibilities including practical advice incl. coffee Group Task - Protocol Fårtickan, Kantarellen/ 4

5 Moderator ES incl. coffee Group Task continued Fårtickan, Kantarellen/ Statistics in clinical trials Catarina Jansson-Blixt Karljohan, Lunch Group Task Critical paper review statistical aspects Catarina Jansson-Blixt Fårtickan, Kantarellen/ 5

6 incl. coffee Adverse events + practical cases EL Karljohan, Moderator MH Quality control, monitoring and GJ Karljohan, archiving Lunch Biobanking and Elvar Theodorsson, Karljohan, 14:20 14:40 14:40 16:00 Coffee PUL Lars-Åke Pettersson/Moa Malviker Wellermark 6

7 Moderator ES incl. coffee Group Task continued Karljohan, O-huset, Kantarellen, plan 10, Kubiken/Kvadraten, ingång 7, plan 10, HB Medical devices in clinical trials Peter Landvall/ES Karljohan, Lunch Medical devices continued Peter Landvall/ES Karljohan, incl. coffee Preliminary report of examination Faculty task Karljohan, O-huset, Kantarellen, plan 10, Kubiken/Kvadraten, ingång 7, plan 10, HB 7

8 Moderator ES/MH incl. coffee Group task continued Fårtickan, Kantarellen/ Lunch Group Task continued Fårtickan, Kantarellen/ Deadline of admission of examination task. Mail to 8

9 incl. coffee Visit at clinical trial units at US Curt Petersson, KPE Moderator ES KPE/BCRC Lena Sundin, BCRC Lunch Preparation of presentation and opposition Group A 8-10 BCRC KPE Group B 8-10 KPE BCRC Fårtickan, Kantarellen/ 9

10 incl. coffee Examination Karljohan, Moderator ES/MH Lunch Examination continued + evaluation Karljohan, 10

11 Kursansvariga och föreläsare: Mats Hammar, professor, överläkare, Hälsouniversitetet, Kvinnokliniken, US Kursansvarig Catarina Jansson-Blixt, statistiker, konsult Gunn Johansson, diplomerad forskningssjuksköterska, Neurologiska kliniken, US Kursansvarig Preben Kjölhede, docent, överläkare, Kvinnokliniken, US Peter Landvall, konsult bioteknik/medicin teknik, Cellwell Stockholm Lotta Lindh-Åstrand, diplomerad forskningssjuksköterska, doktorand; Kvinnokliniken, US Kursansvarig Elisabeth Logander, diplomerad forskningssjuksköterska, Kardiologiska kliniken, US Kursansvarig Curt Pettersson, professor, överläkare, Onkologiska kliniken US, verksamhetschef KPE Elvar Theodorsson, professor, överläkare, IKE/Klinisk kemi Lars-Åke Pettersson, informationssäkerhetschef, Landstinget i Östergötland / Moa Malviker Wellermark, personuppgiftsombud, Landstinget i Östergötland Lena Sundin, chef forskningskliniken, BCRC Eva Swahn, professor, överläkare, Kardiologiska kliniken, US Gunilla Sydsjö, professor, beteendevetare, Kvinnokliniken, US Kursansvarig (eva.swahn@lio.se) Eric Wahlberg, docent, överläkare, Hjärtcentrum, US Nora Östrup, FoU sekreterare, Hjärtcentrum, US Kursadministratör (nora.ostrup@lio.se) Katarina Thor, Medical Product Agency Björn Zethelius, Medical Product Agency 11