The necessity for an understanding and incorporation into daily practice of the principles of GCP is at times difficult to comprehend, particularly from health professionals already well experienced in their own clinical practice. But, this is clinical research and not clinical practice and while the end result of patient/volunteer well being may be common to both, clinical research must also ensure data validity and demonstrate that the international guidelines for the conduct of clinical research have been adhered too.

The key elements of GCP are covered in this presentation however, the focus, is not to have participants remember, for example, the dates relevant to each GCP or ICH milestone, but to appreciate why the regulations are in place and to acknowledge that if the principles of ICH GCP are followed the result will be a clear benefit to their patients and to the clinical trials they may be involved in. Previous attendees at this presentation have commented that the course is considerably more "contextual" than other GCP courses, and that this course really did answer the question of "Why GCP".

The course is recommended for research personnel (data managers, study nurses, investigators etc) who are new to clinical research or who, have not previously attended GCP training. Research staff who have previously received GCP training may also benefit from attendance, although no benefit can be guaranteed� 

Course duration is 1.5 to 3 hrs (duration tailored to the needs of the attendees). Timing of the courses is scheduled as per the level of interest from your region.

Within the field of clinical research the primary and initial challenge facing the Biotech Industry, is, �what will be required to take our organisation from one strong in pre-clinical research to one capable, adept and compliant to the needs of clinical research."

This presentation provides an overview of GCP and a framework of the systems (SOP, staffing etc) that the organisation is likely to require.

The course recognises that in many cases in the Biotech Industry, human resources are limited, the requirement for multi-tasking is high and as such all staff involved with the proposed clinical research would benefit from attendance. Course duration is approximately 2 hrs, if the number of attendees is sufficient, the RAL trainer can conduct the training at your facility. 

Tony Mann has been involved with the pharmaceutical industry since 1984 and in clinical research since 1987. Involvement with multiple therapeutic areas from phase 1 through to post marketing trials within the Asia Pacific region has provided the experiences necessary to put the "practice" into GCP. Tony continues to provide consultancy in all aspects of clinical research to sponsors varying in size from multi-national pharmaceutical companies to smaller bio-tech companies.