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2017
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Clinical Trials Administration Intensive Workshop

Organizing institution
Utrecht University in cooperation with University of California San Diego Extension, Faculty of Medicine (UU)
Course code
M48
Course fee (incl. housing)
€ 695
Level
Advanced bachelor level

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.

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 UMC Utrecht and is a joint effort between the University Medical Center Utrecht, University of California San Diego and the University of Applied Sciences (HU) and is taught by experienced instructors in the field from the three 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.

This course can also be combined with Clinical Trials Monitoring Workshop

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COURSE LEADER

Prof. D.E. Grobbee, MD, PhD, FESC

LECTURERS

Prof. D.E. Grobbee, MD, PhD, FESC (University Medical Center Utrecht), Sergio Guerrero, MD (University of California, San Diego), Dr. Ad van Dooren, PhD (University of Applied Sciences Utrecht) et al.

TARGET GROUP

Nurses, physicians, CRO employees, pharmaceutical company employees and anyone interested in GCP and clinical trials

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

• € 695 - Course + course materials + housing
• € 495 - Course + course materials

DISCOUNTS AND COMBINATIONS
» Overview of all available discounts

The course Clinical Trials Administration Intensive Workshop can be combined with the following courses.

SCHOLARSHIPS

Utrecht Summer School doesn't offer scholarships for this course.

MORE INFORMATION

Maud Verhoef
E: M.S.Jurgens@umcutrecht.nl
P: +31(0)887568153


» Contact Utrecht Summer School

REGISTRATION

Deadline for registration: 01 June 2017

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