PRELIMINARY PROGRAMME ; 3 credits 2009-11-09 MH/LLÅ/GJ/ EL/ Moderator MH ES/NÖ 08.30-12.00 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 12.00-13.00 LUNCH 13.00-14.20 Tutorial group The Declaration of Helsinki - impact on a clinical trial. Discussion in plenum 14.20-14.40 Coffee 14.40-17.00 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
2009-11-10 08.00-10.00 Application to ethics committee, informed consent. Gunilla Sydsjö Rönnen lärosal, ingång 65 eller 64, plan 10, Hälsouniversitet Moderator ES 10.00-10.20 Coffee 10.00 12.00 Group Task - Patient information informed consent. Ethical committee application. 12.00-13.00 LUNCH Rönnen lärosal, ingång 65 eller64, plan 10, Hälsouniversitet, Bersån Ingång 13, plan 12, Kvadraten, plan 10, Huvudblocket 13.00 15.00 incl. coffee Group Task continued Rönnen lärosal, ingång 65 eller64, plan 10, Hälsouniversitet, Bersån Ingång 13, plan 12, Kvadraten, plan 10, Huvudblocket 15.00-16.30 Discussion - Patient information informed consent. Ethical committee application. In plenum Rönnen lärosal, ingång 65 eller 64, plan 10, Hälsouniversitet 2
2009-11-11 08.00-10.00 Group task continued preparations/ Moderator ES questions to MPA 10.00-10.20 Coffee 10.20-12.00 Medical Product Agency role, rules and application. Björn Zethelius, Katarina Thor Fårtickan, Kantarellen/ Karljohan, 12.00-13.00 LUNCH 13.00-15.00 Inspections and audits in clinical trials 15.00 17.00 incl. coffee Group Task Medical Product Agency Katarina Thor, Björn Zethelius Karljohan, Fårtickan, Kantarellen/ 3
2009-11-12 08.00-10.00 Methodology- design, planning and MH/ES Karljohan, Moderator MH reporting of a clinical trial 10.00-10.20 Coffee 10.20-12.00 The responsibility of the sponsor, PKJ sponsor Karljohan, investigator and the head (huvudmannen) including protocol, CRF and informed consent. ES investigator EW head 12.00-13.00 LUNCH 13.00-15.00 Research nurse - role and LLÅ/GJ/EL Karljohan, responsibilities including practical advice 15.00-17.00 incl. coffee Group Task - Protocol Fårtickan, Kantarellen/ 4
2009-11-13 Moderator ES 8.30 10.30 incl. coffee Group Task continued Fårtickan, Kantarellen/ 10.30 12.30 Statistics in clinical trials Catarina Jansson-Blixt Karljohan, 12.30 13.30 Lunch 13.30 16.00 Group Task Critical paper review statistical aspects Catarina Jansson-Blixt Fårtickan, Kantarellen/ 5
2009-11-16 8.30 11.00 incl. coffee Adverse events + practical cases EL Karljohan, Moderator MH 11.00 12.00 Quality control, monitoring and GJ Karljohan, archiving 12.00 13.00 Lunch 13.00 14.20 Biobanking and Elvar Theodorsson, Karljohan, 14:20 14:40 14:40 16:00 Coffee PUL Lars-Åke Pettersson/Moa Malviker Wellermark 6
2009-11-17 Moderator ES 8.30 11.00 incl. coffee Group Task continued Karljohan, O-huset, Kantarellen, plan 10, Kubiken/Kvadraten, ingång 7, plan 10, HB 10.00 12.00 Medical devices in clinical trials Peter Landvall/ES Karljohan, 12.00 13.00 Lunch 13.00 14.00 Medical devices continued Peter Landvall/ES Karljohan, 14.00 16.00 incl. coffee Preliminary report of examination Faculty task Karljohan, O-huset, Kantarellen, plan 10, Kubiken/Kvadraten, ingång 7, plan 10, HB 7
2009-11-18 Moderator ES/MH 8.30 12.00 incl. coffee Group task continued Fårtickan, Kantarellen/ 12.00 13.00 Lunch 13.00 16.00 Group Task continued Fårtickan, Kantarellen/ 23.59 Deadline of admission of examination task. Mail to nora.ostrup@lio.se 8
2009-11-19 8.00 12.30 incl. coffee Visit at clinical trial units at US Curt Petersson, KPE Moderator ES KPE/BCRC Lena Sundin, BCRC 12.30 13.30 Lunch 13.30 16.00 Preparation of presentation and opposition Group A 8-10 BCRC 10.30-12.30 KPE Group B 8-10 KPE 10.30-12.30 BCRC Fårtickan, Kantarellen/ 9
2009-11-20 9.00 12.00 incl. coffee Examination Karljohan, Moderator ES/MH 12.00 13.00 Lunch 13.00 15.00 Examination continued + evaluation Karljohan, 10
Kursansvariga och föreläsare: Mats Hammar, professor, överläkare, Hälsouniversitetet, Kvinnokliniken, US Kursansvarig (matha@imk.liu.se) Catarina Jansson-Blixt, statistiker, konsult Gunn Johansson, diplomerad forskningssjuksköterska, Neurologiska kliniken, US Kursansvarig (gunn.johansson@lio.se) Preben Kjölhede, docent, överläkare, Kvinnokliniken, US Peter Landvall, konsult bioteknik/medicin teknik, Cellwell Stockholm Lotta Lindh-Åstrand, diplomerad forskningssjuksköterska, doktorand; Kvinnokliniken, US Kursansvarig (lotta.lind.astrand@lio.se) Elisabeth Logander, diplomerad forskningssjuksköterska, Kardiologiska kliniken, US Kursansvarig (elisabeth.logander@lio.se 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