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Improving the Regulatory Review Process

Industry and Regulatory Initiatives

  • Book
  • © 1996

Overview

Editors:
  1. Cyndy Lumley

    1. Centre for Medicines Research, Surrey, UK

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    You can also search for this editor in PubMed   Google Scholar

  2. Stuart R. Walker

    1. Centre for Medicines Research, Surrey, UK

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Centre for Medicines Research Workshop (CMRW)

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Table of contents (18 chapters)

  1. Front Matter

    Pages i-xix
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  2. International regulatory review times

    • Neil McAuslane, Stuart Walker
    Pages 1-11

  3. What determines the speed of review: Need for the product, quality of the dossier or efficiency of regulatory authorities?

    • David Jefferys
    Pages 13-23

  4. Company strategies to ensure a quick and efficient review: A biotech company

    • Ralph Smalling
    Pages 25-32

  5. Company strategies to ensure a quick and efficient review: A Japanese company

    • Bram Morgenstern
    Pages 33-40

  6. Company strategies to ensure a quick and efficient review: A transnational company

    • Emily Donnelly, James Ritchie, Steven French
    Pages 41-51

  7. Conditional licensing: Advantages and disadvantages

    • Maria Holz-Slomczyk, Alfred G. Hildebrandt
    Pages 53-66

  8. Dialogue and interaction between regulators and sponsors: Formal, informal or none at all?

    • Dann M. Michols
    Pages 67-74

  9. The use of electronic dossiers or CANDAs: Help or hindrance?

    • Roger Williams, David Isom
    Pages 75-82

  10. The exchange of assessment reports and training of assessors

    • Andre Broekmans
    Pages 83-88

  11. The regulatory assessment report in the new European system

    • Kjell Strandberg
    Pages 89-97

  12. Industry expert reports: An aid to the reviewer?

    • Robert Temple
    Pages 99-104

  13. The use of internal and external experts and advisory boards: The European experience

    • Gorm Jensen
    Pages 105-109

  14. Highlights of the Pharmaceutical Research and Manufacturers Association proposal for FDA reform

    • David R. Savello
    Pages 111-117

  15. Suggestions that might be considered for improving the review process

    • Cyndy Lumley
    Pages 119-130

  16. The ideal future regulatory system: An industry perspective

    • Eve E. Slater
    Pages 131-138

  17. What strategies should be considered for implementation by the end of the century? MHW perspective

    • Kaoru Misawa
    Pages 139-147

  18. What strategies should be considered for implementation by the end of the century? European perspective

    • Rolf Bass
    Pages 149-153

  19. What strategies should be considered for implementation by the end of the century? CBER vision

    • Kathryn Zoon
    Pages 155-162

  20. Back Matter

    Pages 163-171
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Keywords

About this book

Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

Editors and Affiliations

  • Centre for Medicines Research, Surrey, UK

    Cyndy Lumley, Stuart R. Walker

Bibliographic Information

  • Book Title: Improving the Regulatory Review Process

  • Book Subtitle: Industry and Regulatory Initiatives

  • Editors: Cyndy Lumley, Stuart R. Walker

  • Series Title: Centre for Medicines Research Workshop

  • DOI: https://doi.org/10.1007/978-94-009-1788-0

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Kluwer Academic Publishers 1996

  • Hardcover ISBN: 978-0-7923-8706-0Published: 30 April 1996

  • Softcover ISBN: 978-94-010-7297-7Published: 20 September 2011

  • eBook ISBN: 978-94-009-1788-0Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XX, 172

  • Topics: Pharmacology/Toxicology, Medical Law, Public Health

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