Archive: Sponsor Responsibilities for Global Drug Studies

October 5, 2015 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

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 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.

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Learning Objectives

  • 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

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:

Gary B. Freeman, M.S., C.C.R.A.

Click here for complete trainer biographies

 

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