Course Description

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 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.

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Learning Objectives

• Discuss the 23 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

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

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