Foundation knowledge element of the UK Study Guide

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

  • Key topics

    UK / EU Legislation and guidance

    Competent authorities

    Import / Export

    Site and product authorisations

    Defect reporting / Pharmacovigilance

  • Main Tutors

    Alex Hall (In Person)

    Tanya Agombar (In Person)

    ____________________________

  • Included

    Regulatory update session

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have knowledge of the structure and application of current and forthcoming UK and EU legislation relating to the manufacture, control, storage, and supply of medicinal products (Human, veterinary, IMP for clinical trials)

  • It must be noted that delegates will need to maintain and apply their knowledge to fully meet the requirements of the UK QP Study Guide

  • The structure, content and administration of Marketing and site authorisations (MA, MIA, WDA or equivalents)
    The role of the UK and EU Regulatory / Licencing bodies (MHRA/VMD/EMA) including procedures for defect reporting

  • Import and Export requirements for medicinal products
    The impact of trade and recognition agreements on import / export requirements

  • The role of ICH and PIC/s
    Regulations related to Pharmacovigilance and drug safety monitoring

In this portal

Your materials, assignments and assessments will all be provided through this learning portal

You will be notified by email when items are available for you to access...

  • 1 month before the course start date
    ~ You can access your course workbook
    ~ You will be able to download your Preparatory Assignment

  • Day before course start date
    ~ Downloads for workshops and exercises

  • End of each course day
    ~ Answers to exercises where appropriate

  • After course
    ~ Learning assessment
    ~ Course evaluation
    ~ Certificate

Where are we?

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
01622 477781
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You