Course Overview

  • “Thought the pace of the tutors providing the lectures was excellent and their knowledge and openness has made the learning element effective.” Alison Jordan / Bio Products Laboratory, UK
  • “You made what could have been a very dry subject relatable and understandable.” Nigel Hall / Catalent Pharma Solutions, UK
  • “Excellent course, very good and detailed grounding in all aspects of law and administration for medicinal purposes.” Suzanne Moore / Reckitt Benckiser, UK
  • “Course run superbly.” Lee Mileham / Mylan Pharma, UK

Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QPs). 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 extremely popular QP training module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of… Why we have medicines laws and what they seek to achieve The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP The UK medicines legislative framework US and other international pharmaceutical legislation Other relevant laws and guidelines

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’ continuing professional development.

Key Learning Objectives

A deep and detailed understanding of:

  • Why we have medicines laws and what they seek to achieve
  • The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
  • The UK medicines legislative framework
  • US, ICH and other international pharmaceutical legislation and guidance
  • Other relevant laws and guidelines

Course Outline

European Medicines Legislation

  • The legislative framework in the EU
  • EU directives and regulations affecting medicines
  • Organization and function of EMA
  • Rules governing medicinal products in the EU (EudraLex)
  • Importation into the EU and distribution within the EU
  • Powers of the licensing authorities and adverse licensing reports
  • Pharmacovigilance
  • Role of the QP
  • EU marketing authorization, content, structure (CTD) and application routes
  • Variations to marketing authorizations
  • Non-clinical data/toxicology

Manufacturing and Wholesale Authorizations

  • Starting material controls
  • Parallel imports
  • Pack serialization and tracing
  • Managing contract services
  • Controlled drugs

UK Medicines Legislation

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

Other Relevant Legislation

  • US legislation and FDA
  • 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.

Course Tutors

Course tutors will be:

  • Liz Allanson - Liz was formerly manager of the UK MHRA GMP inspectors. 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 specializes 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 ICH Q9.

Subject Sessions

  • Medicines Law – An Introduction
  • EU Law – An Overview
  • Global GMP Legislation
  • Legislation in the EU Affecting
  • Clinical Trials
  • The Role and Duties of the Qualified Person
  • The EU Marketing Authorization Application
  • Format, Content – CTD
  • Marketing Authorization – Routes and Variations
  • The Non-Clinical Dossier/Toxicology
  • Medicines Legislation: Authorizations for Manufacturing, Importing and Wholesale Dealing
  • Medical Devices Legislation
  • Route to Becoming a QP and Eligibility (UK and other Member States)
  • Adverse LicensingSession
  • European Legislation – Advanced Therapy Medicinal Products
  • Mutual Recognition Agreements of Inspection
  • Parallel Imports
  • Comparison of Human and Veterinary Legislation
  • Recalls – EU and US Laws
  • Regulatory Control of Starting Materials
  • UK Medicines Legislation
  • US Pharmaceutical Law
  • International Conference on Harmonization – Organization, Role and Recent GMP Activities
  • The Role of PIC/S (The Pharmaceutical Inspection Cooperation Scheme)
  • Borderline Products
  • Inspections and the Inspectorate
  • Pharmacovigilance
  • Controlled Drugs
  • Product Liability & Other Legislation to be Considered
  • Keeping Up-To-Date

Course Fees

Course cost (excluding VAT)  £3,395.00

DISCOUNTS AVAILABLE
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

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