PharmaSchool: Understanding American GCP

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL010

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Duration: 1 day

Description:

This course covers the key aspects of FDA requirements for Clinical Trials.

Who it is suitable for:

Those involved in conducting clinical trials with sites in the US or conducting international trials under FDA regulations , for example, Project Managers, CRAs, CTAs, investigators, study nurses.

Example content:

Overview of FDA and it’s departments

Overview of Code of Federal Regulations Title 21

Relevant regulations for Clinical Research
FDA Guidelines relating to Clinical Research

When and how CFR applies outside the US

Key differences between US and EU requirements

FDA forms
FDA Inspections

FDA requirements for acceptance of data from non-IND foreign clinical trials

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
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