8 July 2016
on course website
Clinical Trials Administration Intensive Workshop
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
Prof. D.E. Grobbee, MD, PhD, FESC
Nurses, physicians, CRO employees, pharmaceutical company employees and anyone interested in GCP and clinical trials
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.
EUR 495: Course + course materials
EUR 695: Course + course materials + housing
on course website