Course Overview

  • “Course run superbly.” Lee Mileham / Mylan Pharma, UK
  • “Excellent course, very good and detailed grounding in all aspects of law and administration for medicinal purposes.” Suzanne Moore / RB, UK
  • “You made what could have been a very dry subject relatable and understandable.” Nigel Hall / Catalent Pharma Solutions, UK
  • ''Learning element effective.” Alison Jordan / DDD Limited, UK

FULLY SUBSCRIBED - This highly interactive 5 day course is designed to provide the aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding of international pharmaceutical legislation so that they can carry out their duties with skill and authority. We will describe the laws, regulations and guidance that dictate how we must work on a daily basis, we will explain why these laws exist and how they come into being, we will describe the roles and responsibilities of the major international regulatory agencies and we will emphasise the key role that QP and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety.

About this Course

Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QP). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential.

This is equally true for other pharmaceutical technical managers.

This course is approved by the Royal Society of Chemistry as suitable for their members’ CPD.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • Why we have medicines laws and what they seek to achieve
  • European mechanisms for controlling medicinal products
  • UK mechanisms for controlling medicinal products
  • Similarities and differences of other countries relevant legislation e.g. Brazil, Canada, China, India, Japan and USA
  • International harmonisation activities of ICH and PIC/S

Course Outline

European Medicines Legislation

  • The legislative framework in the EU
  • EU directives and regulations affecting medicines
  • Laws governing clinical trials and investigational medicinal products
  • Organisation and function of EMA
  • EU GMP (EudraLex volume 4)
  • EU marketing authorisation, content, structure (CTD) and application routes
  • Variations to marketing authorisations
  • Non-clinical data/toxicology
  • Importation into the EU and distribution within the EU
  • Powers of the licensing authorities and sanctions that can be imposed
  • Pharmacovigilance

Manufacturing and Wholesale Authorisations

  • Starting material controls
  • Parallel imports
  • Controlled drugs

UK Medicines Legislation

  • Background and development of UK medicines legislation
  • MHRA and VMD

Other Relevant Legislation

  • US legislation and FDA
  • Other major market’s legislation
  • International Council for Harmonisation (ICH)
  • PIC/S
  • Medical devices and combination products

We provide an optional post-course assessment.

Who Should Attend

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their Continuing Professional Development. Taken with some of our other QP modules, this course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications.

Find out why you should choose NSF for your QP training by visiting our qualified person training section

Course Tutors

Lynne Byers

Lynne has over 35 years’ experience, much of it in senior quality management positions. She was formerly manager of UK MHRA inspections and licencing. She has a wealth of knowledge on pharmaceutical law and its practical application.

Rachel Carmichael 

Rachel is a former UK MHRA GMP inspector. She has extensive knowledge of pharmaceutical law and its practical implementation.

Peter Gough 

Peter has over 40 years’ experience in the pharmaceutical industry and specialises in EU and US pharmaceutical law. He has had direct involvement in discussions with regulators on quality and GMP having been the EU industry leader on the ICH Q9 working group.

Plus guest speakers including one from the UK MHRA

Course Fees

Course cost (excluding VAT)  £3,500.00


Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities – contact us for details.

Have a question or want to book a place? Contact you can also register online by clicking below.