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eBook Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop) ePub

eBook Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop) ePub

by Neil McAuslane,Stuart R. Walker,N. McAuslane,S.R. Walker

  • ISBN: 0792387317
  • Category: Medicine and Health Sciences
  • Subcategory: Other
  • Author: Neil McAuslane,Stuart R. Walker,N. McAuslane,S.R. Walker
  • Language: English
  • Publisher: Springer; 1 edition (February 28, 1998)
  • Pages: 192
  • ePub book: 1954 kb
  • Fb2 book: 1136 kb
  • Other: lrf mobi docx rtf
  • Rating: 4.8
  • Votes: 130

Description

Centre for Innovation in Regulatory Science.

Centre for Innovation in Regulatory Science. A Study of Trends in Pharmaceutical Regulatory Approval Times for Nine Major Markets in the 1990s.

4. Current Regulatory Reforms: CBER K. Zoon

4. Zoon.

Автор: N. McAuslane; .

Автор: N.

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Magdalena Bujar1,2, Neil McAuslane1, Stuart R. Walker1 and Sam Salek2,3 .

Magdalena Bujar Neil McAuslane Stuart R Walker Sam Salek. Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK; Institute for Medicines Development, Cardiff, UK. Electronic address: View Article. Front Pharmacol 2017 10;8:189. Epub 2017 Apr 10. Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of d, UK. View Article.

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.