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, including R2 updates) 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.

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

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Click here for complete trainer biographies

Registration Fees

$735

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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-20-065-L04-P. Released: 9/20. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.