GCP: A Condensed Review for the Busy Professional

This one-day seminar, worth six contact hours/credits, is designed to introduce Good Clinical Practice (GCP)/International Conference of Harmonization (ICH) E6 to clinical research personnel that are new or relatively new to developing products (drugs) for patient care.  It is intended to help you begin your preparation to conduct clinical trials in an ethical manner according the regulations and international guidelines. Whether you are a clinical research physician, investigator, study coordinator, or other member of the study team, this program will provide you with the intensive training needed to improve your trials and ensure compliance with Good Clinical Practice, FDA Regulations, and ICH Guidelines.

Upcoming Dates & Locations

• Philadelphia, Pa., Sept. 6, 2008

Course Objectives

At the conclusion of the program, participants will be able to:

• Appreciate the global scope of clinical research
• Review the history of GCP/ICH Guidelines
• Describe the function of Institutional Review Boards/Ethics Committees and how human subjects are protected by them
• Recognize the respective roles of the investigator, coordinator, sponsor and monitor during the appropriate execution of a clinical drug trial
• Define the involvement of the FDA in the execution of a clinical trial