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Archive: ABCs of GCP and the 13 Principles of ICH GCP E6
Course Description
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 the ICH GCP E6 Guideline) 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 the ICH GCP E6 Guideline will be discussed in a practical manner to ensure compliance with all regulatory requirements.
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Learning Objectives
- 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 E6 to quality research studies to ensure compliance
Who Should Attend
- Clinical Research Associates
- Project Managers
- Study Coordinators
- Investigators
- Regulatory Affairs Professionals
- Institutional Review Board Professionals
- All other personnel responsible for ensuring compliance with GCP regulations
Instructor
Gary B. Freeman, M.S.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.