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.
- 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
- 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
Gary
B. Freeman, M.S.
Click here for complete trainer
biographies
$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.
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#: 0778-0000-17-017-L01-P.
Released: 4/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.