This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. 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:
- How to conduct a clinical trial, Phase I-IV studies including principles of working in a regulated environment; discuss 21 CFR part 11, 50, 54, 56, 312 and 812, Good Clinical Practice (GCP)/ICH guidance (specifically ICH E6), and the IND/IDE process.
- Ethics of clinical trials including historical background, current issues and current Regulatory observations.
- How to survive an FDA clinical audit and the common findings that have been cited on FDA 483s and Warning Letters.
- How to collect and organize essential study documents that are required before a clinical trial initiation, during trial conduct and once the study is completed.
Who Will Benefit:
This webinar will provide valuable assistance to all personal in:- Pharmaceutical
- Biotechnology
- CROs
- Research facilities conducting clinical trials
Course Provider
Elizabeth Bergan,
