Foundation knowledge element of the UK Study Guide

What the QP needs to know and how it all works in practice

  • Key topics

    Clinical Trial Design & Trial Phases

    Clinical Trial Management

    Protecting the Patient
    Legal Framework for Clinical Trials

    Clinical Trial Documentation

    Manufacture, testing, packaging, labelling, blinding, randomisation of IMP

    Duties and responsibilities of the QP and the Sponsor

    Applying for a Clinical Trial

    IMP Supply Chain

  • Main Tutors

    Helen O'Shea

    Corryn Gardiner

  • Included

    Workshops, exercises, assessment

    Clinical trials: the future

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have an understanding of the requirements for manufacture, control, and distribution of Investigational Medicinal Products (IMP)

  • Understanding of the requirements and implementation of UK and EU legislation for IMPs, including Clinical Trial Regulation 536/2014 and its knock on effects to Good Manufacturing Practice

  • Knowledge and understanding of the regulatory structure of the Clinical Trial Application, including the IMPD, and Product Specification File

  • Understanding of clinical trial design, the impact of the different clinical trial phases on design and manufacturing and the ethical requirements for conducting trials in human subjects (Good Clinical Practice) including safety reporting requirements

  • How a risk based approach is applied to development and application of manufacturing, and control parameters for IMP, including levels of validation required for processes

How to find us:

Location: Maidstone Innovation Centre
Gidds Pond Way,Weavering, Maidstone, Kent ME14 5FY

Maidstone is very accessible by car, with the M2 and M20 motorways providing easy connections to the M25.

Southeastern run trains across the county and Maidstone town centre benefits from two railway stations. Maidstone East connects to London and Ashford, while Maidstone West links to Gatwick and Tonbridge.
how to find us

Want to know more, find out about the discount bundles available, or book your training

Call us directly on
07521 219381 (tue - thur)
email us
[email protected]
or pop your email in the box below and we will get right back to you

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