Course Description

This web seminar covers the sponsor’s responsibilities for the conduct of a global drug study. Participants will learn the responsibilities assigned to a sponsor for a global clinical study based on the International Council for 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.

Learning Objectives

• Discuss the sponsor responsibilities assigned in ICH GCP E6 Guideline 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

Who Should Attend

• 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)

Instructor

The course will be led by one of the following instructors:

Treena Jackson, M.S., M.A., C.Q.A., R.A.C., C.S.S.G.B.

Maria Veleva, M.D.

Click here for complete trainer biographies

Registration Fees

$735*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com 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#: 0778-0000-24-028-L99-P. Released: 2/24. 

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