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Improving the Regulatory Review Process: Assessing Performance and Setting Targets

  • Book
  • © 1997

Overview

Editors:
  1. Neil McAuslane

    1. Centre for Medicines Research International, Carshalton, Surrey, UK

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  2. Stuart Walker

    1. Centre for Medicines Research International, Carshalton, Surrey, UK

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    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 (12 chapters)

  1. Front Matter

    Pages i-xix
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  2. Assessing performance and setting targets

    • Terry Eaves
    Pages 1-12

  3. Current regulatory reforms and improvements in the review process

    • Fernand Sauer
    Pages 13-19

  4. Current regulatory reforms: CBER

    • Kathryn Zoon
    Pages 21-28

  5. Improving the review process: The view of the Japanese MHW

    • Yoshinobu Hirayama
    Pages 29-40

  6. Comparing the performance of the Canadian TPD with other regulatory authorities

    • Beth Pieterson
    Pages 41-48

  7. Measuring performance: The view of the TGA

    • John McEwen
    Pages 49-59

  8. Why have targets for the review process? The view of the EMEA

    • Rolf Bass
    Pages 61-71

  9. Why have targets for the review process? An individual viewpoint

    • Emily Donnelly
    Pages 73-85

  10. Key milestones in the regulatory review process

    • Kate Thomas
    Pages 87-113

  11. How do you measure the quality of the scientific assessment and the review process? The view of the MCA

    • David Jefferys
    Pages 115-123

  12. Ensuring the quality of the scientific assessment and the review process: The FDA’s good review practice initiative

    • Murray Lumpkin
    Pages 125-133

  13. Outcome of syndicate discussions

    • Neil McAuslane, Stuart Walker
    Pages 135-150

  14. Back Matter

    Pages 151-163
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Keywords

About this book

At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance.
The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.

Editors and Affiliations

  • Centre for Medicines Research International, Carshalton, Surrey, UK

    Neil McAuslane, Stuart Walker

Bibliographic Information

  • Book Title: Improving the Regulatory Review Process: Assessing Performance and Setting Targets

  • Editors: Neil McAuslane, Stuart Walker

  • Series Title: Centre for Medicines Research Workshop

  • DOI: https://doi.org/10.1007/978-94-011-4874-0

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Kluwer Academic Publishers 1997

  • Hardcover ISBN: 978-0-7923-8731-2Published: 28 February 1998

  • Softcover ISBN: 978-94-010-6042-4Published: 05 November 2012

  • eBook ISBN: 978-94-011-4874-0Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XIX, 163

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

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