22 July 2016
on course website
Clinical Trials Monitoring Workshop
The Clinical Trials Monitoring Workshop both offers 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.
This course is connected to the Clinical Trials Administration Intensive Workshop and can be followed directly afterwards. The first week will offer additional theoretical knowledge about the theory and principles of GCP, in addition to the topics covered in Clinical Trials Administration Intensive Workshop. The focus will be on the European rules directives and regulations, with a stronger focus on clinical research monitoring. 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 solely 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 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 course is organized by the HU University of Applied Sciences and is a joint effort between the HU University of Applied Sciences (HU), the University Medical Center Utrecht, and the University of California San Diego.
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.
- Introduction to Pharmacoeconomics.
- Workshop: Job applications.
- Workshop: Monitoring clinical trials.
- Workshop: Communicating as a CRA (written reports, oral discussions)
- Workshop: Presentations
Hans Vehof MSc
Nurses, physicians, pharmaceutical business administrators, CRO employees, pharmaceutical company employees and anyone interested in GCP and clinical trials.
Basic knowledge, acquirable in the Clinical Trials Administration Intensive Workshop, is a prerequisite.
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.
EUR 990: Course + course materials
EUR 1340: Course + course materials + housing
on course website