6 th – 7 th November 2017 Teaching Theater IMERI Building, 6 th Floor Clinical Research Supporting Unit IMERI Building Tower A floor 11 Mobile office hour: 0812 97527547 Email: crsu.fkui.ac.id Registration Fee: Rp 3.000.000,- Bank Bukopin 700-247-11111-0000-9 a.n. Workshop FKUI Programme Clinical Trials: What and How Clinical Trial on Medical Devices Declaration of Helsinki Principles and Implementation of ICH-GCP Role and Responsibility of Ethics Committee Information for Subjects and Informed Consent Role and Responsibility of Investigator Role and Responsibility of Sponsor Role and Responsibility of Monitor CRF filling and AE/SAE reporting Investigator’s Brochure and Essential Document Audit in Clinical Trial www.icgh.ui.ac.id/registration Certificate attandances Certificate competence Lunch & Snack Workshop kit