Improving the Regulatory Review Process

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.