This web seminar provides the basic concept of Good Clinical Practice (GCP). Participants will learn the goals of GCP and its common elements (FDA regulations and ICH Guidelines) defining the quality system of mutual accountability between the sponsor, investigator, IRB/IEC, and the regulatory authority. The basic roles and responsibilities of each stakeholder will be discussed in relation to these criteria. The 13 principles of ICH GCP will be discussed in a practical manner to ensure compliance with all regulatory requirements.
- Describe the goals of GCP
- Discuss the various regulations affecting drug, device, and biologic investigational products related to GCP
- Recognize the mutual accountability and responsibilities for each of the stakeholders: Sponsor, investigator, IRB/IEC, and regulatory authority
- Apply the 13 principles of ICH GCP to quality research studies to ensure compliance
- Clinical Research Associates
- Project Managers
- Study Coordinators
- Regulatory Affairs Professionals
- Institutional Review Board Professionals
- All other personnel responsible for ensuring compliance with GCP regulations
Gary B. Freeman, M.S., C.C.R.A.
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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 1.5 hours (0.15 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#: 0778-0000-14-068-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.