Disciplines

Clinical Trials Administration Intensive Workshop

Organizing institution
Utrecht University - Faculty of Medicine
Course code
M48
Course fee (excl. housing)
€ 495.00
Level
Advanced Bachelor
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The Clinical Trials Administration Intensive Workshop provides a solid foundational overview of the principles upon which clinical trials are based from both a European and US perspective. Covered topics: drug development process, ICH/FDA regulations, investigator's brochure, trial design, protocol, case report forms, study reports, the EC/IRB, IP pipeline, principles of GCP, data analysis and reporting, adverse and serious adverse events, monitoring, study closeout, and many more.

This week-long course provides a solid foundational overview of the principles upon which clinical trials are based from both a European and a US perspective. Covered topics: drug development process, ICH/FDA regulations; investigator’s brochure; trial design, protocol; case report forms; study reports; the EC/IRB; IP pipeline; principles of GCP; data analysis and reporting; adverse and serious adverse events; monitoring; study closeout; and more. Program benefits include identification of practical skills and knowledge to build confidence for assuming clinical trial-related roles within the industry; and the opportunity for networking with professional peers. The course is organized by the University Medical Center Utrecht and is a joint effort between the UMC Utrecht and University of California San Diego. The course is taught by experienced instructors in the field from these two institutes.

After the course participants may choose to apply for the University of California, Extension Clinical Trials Administration Certificate program, offered via Elevate Health, which consists of the Clinical Trials Administration Intensive Workshop and additional online elective courses.
Download the day-to-day programme (PDF)

Course director

Prof. K.C.B. Roes, PhD

Lecturers

Prof. K.C.B. Roes, PhD, (University Medical Center Utrecht), S. Guerrero, MD (University of California, San Diego), A. van Dooren, PhD.

Course aim

Students will gain a solid foundation in the principles upon which clinical trials are based. Program benefits include identification of knowledge to work in clinical trials; knowledge to build confidence for assuming responsible roles within the industry; and the opportunity for networking with professional peers.

Study load

TBA

Fee

€ 495.00
Housing € 200.00 , through Utrecht Summer School

More information

Registration

Application deadline: 18 June 2018