21 July 2017
on course website
Clinical Trials Monitoring Workshop
The Clinical Trials Monitoring Workshop offers both advanced knowledge of GCP and European rules and regulations with respect to clinical trials design, execution and reporting, and will provide students with many of the skills needed to fulfill the roles of a Clinical Research Associate.
The first week will offer theoretical knowledge about the theory and principles of GCP. The focus will be on the European rules directives and regulations. Furthermore, the first week includes role plays, debates and workshops, for instance in dealing with ethical issues, market access, job applications and communication skills. This will lead to better understanding of the ins and outs clinical drug development in general and CRA qualifications in particular. The second week will be devoted to hands-on monitoring of patient dossiers and CRFs.
Last years students responded enthusiastically to the workshop:
-"The monitoring cases are really good and it introduces me to the field work monitoring"
-"I enjoyed to do monitoring independently. It gives practical skills that are a bit difficult to understand if you just read it theoretically"
-"I feel quite confident now to start a job as a CRA and learn things that a CRA has to keep in mind”
- “Practical and hands-on, appreciate the interaction between teacher and students”
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 preliminary program includes the following topics (subject to change):
- Monitoring aspects. Risk based monitoring. CRA responsibilities.
- European registration, EMA, CTA, Eudract. Directives and regulations.
- Ethical issues. Philosophy of science.
- An introduction to Pharmacoeconomics.
- Workshop: Monitoring clinical trials.
- Workshop: Communicating as a CRA (written reports, oral discussions)
- Workshop: Presentations
- Workshop: Job applications
Hans Vehof MSc
Nurses, physicians, pharmaceutical business administrators, CRO employees, pharmaceutical company employees and anyone interested in GCP and clinical trials.
Students will gain advanced knowledge of the principles upon which clinical trials are based. Furthermore, the purpose of this course is to obtain practical experience in clinical trial monitoring. The program also includes role plays, debates and workshops, which will lead to better understanding of the ins and outs of the pharmaceutical industry in general and clinical drug development in particular.
Certificate of Attendance
EUR 1340: Course + course materials + housing
EUR 990: Course + course materials
Utrecht Summer School doesn't offer scholarships for this course.Register for this course
on course website