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

    Ilona Stezowska

    Helen O'Shea

  • 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

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.

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

Call us directly on
07521 219981 tues - thurs
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You