EFGCP Interactive Investigator Training for Inspections
Organization: European Forum for Good Clinical Practice (EFGCP)
Venue: UCH Education Centre
|Event Date/Time: Nov 19, 2012||End Date/Time: Nov 19, 2012|
This one-day course is aimed at clinical trial centre staff such as investigators, co-investigators, study nurses and coordinators and anyone who is involved in the conduct of clinical trials of any phase and design, sponsored by commercial or academic institutions. Inspections are no longer linked to a submission by a sponsor to Health Authorities to obtain a marketing authorization but in the today’s inspection landscape inspections can occur at any time with and without a particular event triggering these. Especially in Europe, Health Authorities conduct inspections as part of their routine oversight activity. For clinical trial centre staff it is, therefore, important to understand what is required during an inspection, how to prepare for and follow-up on an inspection. It is also important to understand and apply new trends such as the concept of a risk based approach that is becoming the reference for inspectors.
This is the first seminar and although being held in London it will address not only UK specificities but also general and EU themes.