Protection of human research subjects and data integrity are the two central tenets of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) worldwide. In this interactive web seminar you will learn how the U.S. Food and Drug Administration (FDA) and Health Canada have interpreted ICH GCP guidance. Case studies and other interactive techniques will be used to provide participants with a deeper understanding of clinical research requirements and best practices according to the FDA and Health Canada drug regulations. This web seminar will provide an in-depth focus on drug regulations.
- Review key guidance documents: The Belmont Report (U.S.) and the Tri-Council Policy Statement (Canada)
- Describe the similarities and differences in Institutional Review Boards and Research Ethics Boards
- Determine investigator and sponsor obligations
- Examine essential documentation; from informed consent to archiving requirements
- Discuss inspection process and recent findings
- Implement best practices in conducting clinical studies according to the FDA and Health Canada drug requirements
- Site Research Managers and Coordinators
- Clinical Research Monitors
- Project Managers
- Clinical Research Associate Managers
- Clinical Research Directors
- Regulatory Affairs Professionals
Natalie Currie, BSc.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-068-L01-P. Released: 8/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.