PharmaSchool: UK Clinical Trials Legislation - the Statutory Instruments (SIs)

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: GGL005

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Duration: 1 day

Description:

This course provides a basic working knowledge of the legislation and guidance governing clinical trials in the UK.

Who it is suitable for: The course is aimed at those working in clinical trials in the UK, for example:

Project Managers
CRAs
CTAs
Auditors
Investigators
Research Nurses

Example content:

Background and History of Clinical Research Legislation in the UK

European legislation and its impact on the UK
Development of UK legislation
UK regulatory and advisory bodies

Statutory Instruments

Structure
Contents
Workshop session on implications for Sponsors, Monitors and Investigators

MHRA Guidance

Latest guidance on key issues

Future Developments

Overview of TGN 1412 incident
Recommendations of Expert Working Group

ABPI Guidance on Phase I 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

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Previous Course Feedback: UK Clinical Trials Legislation - the Statutory Instruments (SIs)
Customer: Health Service Organisation
Number of Participants: 12
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Average score: 9.5
Participant Feedback :
Good tutor made the subject interesting
A course I very much needed and enjoyed
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