PharmaSchool: Introduction to 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: GGL001

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Duration: 1 or 2 Days

Description:

This course provides a basic working knowledge of GCP.

Who it is suitable for:

This course is aimed at those new to clinical research. The content can be tailored to the function of the audience, for example, CRAs, CTAs, support staff, staff from service providers.

Example content:

Background and history to Clinical Trials legislation

Nuremberg Code
Declaration of Helsinki
Historical context and drivers
Development of international GCPs

ICH GCP

Background
Contents
Responsibilities of Ethics Committees, Sponsors and Investigators
Essential Documents

FDA 21CFR

Background
Key differences
FDA inspections overview

EU Directives governing clinical research

European legal framework
Clinical Trials Directive
Clinical Trials Guidelines
GCP Directive
GMP Directive

UK Statutory Instruments (optional)

Clinical Trials
Human Tissue Act
UKECA and NRES

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

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Previous Course Feedback: Introduction to GCP
Customer: Pharma Company
Number of Participants: 14
How well fulfilled were your personal objectives for this course?
Fully (86%)
Well (14%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (93%)
Fair amount (7%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (100%)
Fair amount (0%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.9
Participant Feedback :
Great Introduction, just what we needed
Made me see it is more than just GCP
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