Improving the Regulatory Review Process

. Ed(s): Lumley, C.E.; Walker, Stuart R.

ISBN 10: 0792387066 / ISBN 13: 9780792387060

Editore: Kluwer Academic Publishers, 1996

Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. The proceedings of the 11th CMR Workshop, held in September 1995 and reproduced in this book, provide an overview of the current review process around the world. Editor(s): Lumley, C.E.; Walker, Stuart R. Series: Centre for Medicines Research Workshop. Num Pages: 172 pages, biography. BIC Classification: MMG; TDCW. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly. Dimension: 297 x 210 x 12. Weight in Grams: 454. . 1996. Hardback. . . . . Books ship from the US and Ireland. Codice articolo V9780792387060

Riassunto:

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.

Contenuti: 1. International Regulatory Review Times; N. McAuslane, S. Walker. 2. What Determines Speed of Review: Need for the Product, Quality of Dossier or Efficiency of Regulatory Authories? D. Jefferys. 3. Company Strategies to Ensure a Quick and Efficient Review: A Biotech Company; R. Smalling. 4. Company Strategies to Ensure a Quick and Efficient Review: A Japanese Company; B. Morgenstern. 5. Company Strategies to Ensure a Quick and Efficient Review: A Transnational Company; E. Donnelly. 6. Conditional Licensing: Advantages and Disadvantages; M. Holz-Slomczyk, A. Hildebandt. 7. Dialogue and Interaction Between Regulators and Sponsors: Formal, Informal or None at All? D. Michols. 8. The Use of Electronic Dossiers or CANDAs: Help or Hindrance? R. Williams. 9. The Exchange of Assessment Reports and Training of Assessors; A. Broekmans. 10. The Regulatory Assessment Report in the New European System; K. Strandberg. 11. Industry Expert Reports: An Aid to the Reviewer? R. Temple. 12. The Use of Internal and External Experts and Advisory Boards: The European Experience; G. Jensen. 13. Highlights of the Pharmaceutical Research and Manufacturers Associaton Proposal for FDA Reform; D.R. Savello. 14. Recommendations to Improve the Review Process; C. Lumley. 15. The Ideal Future Regulatory System: An Industry Perspective; E.E. Slater. 16. What Strategies Should be Considered for Implementation by the End of the Century? MHW Perspective; K. Misawa. 17. What Strategies Should be Considered for Implementation by the End of the Century? European Perspective; R. Bass. 18. Future Perspectives: What Strategies Should be Considered for Implementation by the End of the Century? FDA Perspective; K. Zoon. Index.

Dati bibliografici

Titolo: Improving the Regulatory Review Process
Casa editrice: Kluwer Academic Publishers
Data di pubblicazione: 1996
Legatura: Rilegato
Condizione: New