Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations. The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP and are required for any company that conducts trials on human subjects.
At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are “best practices” derived from regulations, guidances, and industry standards and practices and not all found in black and white in the regulations.
Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries. This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.
Areas to be Covered:
Define Good Clinical Practice (GCP)
Outline the goals of GCP
Provide a historical perspective on GCP
Outline FDA regulations relating to GCP in medical device research
How to implement GCP
How FDA Inspects for GCP
How FDA GCP relates to international regulations
Who will Benefit:
Regulatory Authority Inspectors
Clinical Safety Personnel
Data Monitoring Companies
Clinical Data Management Teams
IT personnel working on Clinical Systems