QP pharmaceutical law and administration

2 Day/s

CPD Hours: 14

Classroom, Online, in-house, eLearning

RSC approved

The Qualified Person (QP) must have a thorough knowledge and understanding of European and UK Laws related to the manufacture and distribution of medicinal products for human and veterinary use.

This course provides a comprehensive overview of the requirements of the UK Study Guide and, by using interactive questions and scenarios, shows how the Qualified Person or anyone with a responsible position within the pharmaceutical industry can keep up to date and assure compliance.

RSC Logo Approved Training High Res (1)
This is an essential course for candidates who expect to apply for their QP viva within one year. The course also provides a valuable contribution to Continuing Professional Development for existing QPs and all other managers or supervisors with responsibilities for manufacturing medicinal products. For those not directly related to manufacturing it provides a valuable overview of the regulatory framework by which medicines are controlled.

This course includes the following topics :

  • Day 1
    • Introduction & pre-course work review
    • UK/EU Legislative Process
    • Introduction to UK/EU Pharmaceutical Legislation
    • Obligations of Marketing Authorisation Holders
    • Labelling Regulations
    • GMP Regulations
    • QP Scenario
    • Clinical Trial Regulations
    • Site Authorisations
    • Manufacturing Import License
  • Day 2
    • Product Authorisations
    • CTD Module 3
    • Pharmacopoeias & the EDQM
    • MHRA, EMA & VMD
    • Pharmacovigilance
    • Import / Export / Distribution
    • Importing from 3rd countries
    • Harmonisation of guidelines
    • Introduction to the FDA
    • Pharmaceutical Supply Chain

    At the end of the course you will know and understand:

    • The UK laws and European Directives for the manufacture and distribution of medicinal products for human and veterinary use
    • Clinical Trial Legislation
    • Product and Site licensing in the UK and EU
    • Role and structure of the EMA, MHRA & VMD
    • Pharmacovigilance requirements
    • The role of the pharmacopoeias and EDQM
    • International harmonisation, ICH, PIC/S and Mutual Recognition Agreements
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Special offer

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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

Sue Mann

Sue has run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

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