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Law and Regulation of Medicines

Law and Regulation of Medicines

  • 作者：
  • 出版商： Oxford University Press
  • ISBN: 9780199534678
  • 出版时间 August 2008
  • 规格： Hardback , 528 pages
  • 适应领域： U.K. ? 免责申明：
    Countri(es) stated herein are used as reference only
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  • 详细

    • A comprehensive review of current science, medicine and the law of regulation, consumer protection and intellectual property of new medicines in the UK
    • Written by a leading and authoritative team of legal and scientific experts
    • Focused on practical understanding and implementation of legal and scientific issues through the use of flow diagrams and checklists
    • Written in clear language to facilitate mutual understanding between lawyers and scientists

    This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is a reference work and source of expertise for legal, medical, and pharmaceutical professionals working in the fields of medicine regulation, medical law and product liability.



    Written by an author team comprising specialists in pharmaceutical medicine, pharmacology and therapeutics, and lawyers specialising in product liability law and intellectual property, this book reviews all the areas of science, regulatory policy and legislation, together with the consumer protection and intellectual property law as applicable to the development and commercialisation of medicinal products.



    Serving as a practical introduction for practitioners wishing to undertake work in this highly complex area of law, this book is specifically designed to facilitate deeper mutual understanding of the scientific and technical issues for the lawyer, and the legal issues for those involved with regulatory policy and decision making and senior executives in the pharmaceutical industry.



    The work covers the European and UK legislation on medicines and healthcare products, including the principal directives and regulations, together with UK implementing legislation and instruments, and the key case law. It covers the structure and function of the regulatory authorities, applications to carry out clinical trials, intellectual property issues, product liability issues and litigation.



    This book provides practical guidance on drafting regulatory submissions, preparing litigation against decisions of the regulatory authorities; determining appropriate regulatory submission strategies throughout the European Community, and preparing litigation relating to medicinal products liability under the Product Liability Directive and the Consumer Protection Act 1987.

    Readership: Primary: Solicitors firms and barristers specialising in medical law, product liability and regulatory law; and in-house legal and regulatory departments of pharmaceutical companies. Secondary: Law schools teaching healthcare subjects, particularly postgraduates on LLM medical law courses; medical school departments of clinical pharmocology and therapeutics and medical school libraries.

  • Introduction1:


    Dr Peter Feldschreiber and Sir Alasdair Breckenridge: The Structure and Function of Medicines Regulation in Europe


    Simon Rogers: Medicines Legislation


    The Regulation of Medicines2:


    Roy Alder CBE: Roles and Responsibilities of the Regulator


    Dr Peter Feldschreiber: Marketing Authorization


    Dr Ian Hudson: Regulation of Clinical Trials


    Dr John Warren: The Regulatory Process: Pharmacovigilance in Practice


    Dr Peter Feldschreiber: Compliance and Enforcement in the UK


    The Law of Medicines3:


    Leigh-Ann Mulcahy: Civil Law Liability


    Leigh-Ann Mulcahy: Public Law Liability


    Jalil Asif: Criminal Liability


    Jalil Asif: General Product Safety Law


    Julian Acratopulo and Dr Alexandra McConnell: Practical Aspects of Healthcare Product Liability Litigation


    Alexander Denoon, Daniel Royle, and Anne Christopher: The Law: Intellectual Property


     


     



  • Edited by Peter Feldschreiber, Barrister, Four New Square, Lincoln's Inn and Senior Medical Assessor, Medicines and Healthcare Products Regulatory Agency

    Contributors:

    Professor Sir Alasdair Breckenridge CBE, Chairman, MHRA


    Roy Alder CBE, Previous Director of Policy, MHRA


    Simon Rogers, Office of the Government Solicitor


    Dr Peter Feldschreiber Barrister, Four New Square Lincolns' Inn


    Dr Ian Hudson, Director of Licensing Division, MHRA


    Dr John Warren, Senior Medical Assessor, MHRA


    Julian Acratopulo, Solicitor, Clifford Chance LLP


    Alex Denoon, Solicitor, Clifford Chance LLP


    Anne Christopher, Clifford Chance LLP


    Daniel Royle, Clifford Chance LLP


    Alexandra McConnell, Solicitor, Clifford Chance LLP


    Jalil Asif, Barrister, Four New Square


    Leigh-Ann Mulcahy, Barrister, Four New Square and Treasury Counsel, A Panel



    Consultant Editors: Justin Fenwick QC, Four New Square & Jeremy Stuart-Smith QC, Four New Square

  • ""This is a superb textbook. It should be required reading and used as a reference source for all those involved in the development, regulation and legal practices of Medicines." District Judge Stephen Gold"


     


     



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