PharmaSchool: Understanding American GCP

Please contact Jo Burmester at to find out more about in-house courses and discuss your specific needs.

Course Code: GGL010

Enquire about course

Duration: 1 day


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.
For information about Open Courses click here or for
online learning click here

Show all Customised In-house Courses

PharmaSchool Course Enquiry Form:
Your Name:
Your Company:
Your Enquiry
Approx Number of People
Proposed Location
Preferred Contact Method
Top of Page
PharmaSchool Logins

Learning Management Centre
CPMC Login
My GCP Zone Login
Retrieve Online Order

Free GCP & Regulatory Updates

GCP Challenges
from PharmaSchool

Over the last 12 years PharmaSchool has provided a free weekly GCP & Clinical Research related challenge. With nearly 3 quarters of a million attempts at these Challenges they are used across the World to test, learn and document knowledge.

Clinical Research Random Questions
GCP by Numbers
EU Medical Devices Regulation
Risk Based Monitoring

Click to see the full range of Challenges>

News & Corporate Information