6th

– 7th

November 2017 Teaching Theater

IMERI Building, 6th 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