This web seminar covers the sponsor’s responsibilities for the conduct of a global drug study. Participants will learn the 23 responsibilities assigned to a sponsor for a global clinical study based on the International Conference on Harmonization (ICH) requirements. These essential requirements for compliance to regulations are useful when dealing with the FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and Health Canada (HC), among other global regulatory authorities. Focusing on the importance of documentation, participants will learn how to put these concepts into practice.
- Discuss the 23 sponsor responsibilities assigned in ICH GCP and expected by the regulatory authorities across the globe
- Describe how these concepts are put into practice, with special focus on documentation to support sponsor oversight of these responsibilities
- Clinical Operations Staff
- Project Managers
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- All other personnel responsible for ensuring compliance with sponsor responsibilities in the conduct of a clinical trial (especially for start-up and
smaller biotech companies)
Gary B. Freeman, M.S., C.C.R.A.
Click here for complete trainer biographies
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#: 0778-0000-15-071-L01-P. Released: 7/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.