Event Date/Time: Sep 30, 2008
This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
Areas Covered in the seminar:
* Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process.
* Ethics of clinical trials including historical background, current issues and current Regulatory observations.
* Essential study documents that are required before trial initiation, during trial conduct and study close-out.
Who will benefit:
This webinar will provide valuable assistance to all personal in: