Improving the Regulatory Review Process

1 International regulatory review times.- 2 What determines speed of review: Need for the product, quality of the dossier or efficiency of regulatory authorities?.- 3 Company strategies to ensure a quick and efficient review: Abiotech company.- 4 Company strategies to ensure a quick and efficient review: A Japanese company.- 5 Company strategies to ensure a quick and efficient review: A transnational company.- 6 Conditional licensing: Advantages and disadvantages.- 7 Dialogue and interaction between regulators and sponsors: Formal, informal or none at all?.- 8 The use of electronic dossiers or CANDAs: Help or hindrance?.- 9 The exchange of assessment reports and training of assessors.- 10 The regulatory assessment report in the new European system.- 11 Industry expert reports: An aid to the reviewer?.- 12 The use of internal and external experts and advisory boards: The European experience.- 13 Highlights of the Pharmaceutical Research and Manufacturers Association proposal for FDA reform.- 14 Suggestions that might be considered for improving the review process.- 15 The ideal future regulatory system: An industry perspective.- 16 What strategies should be considered forimplementation by the end of the century? MHW perspective.- 17 What strategies should be considered for implementation by the end of the century? European perspective.- 18 What strategies should be considered for implementation by the end of the century? CBER vision.- Meeting participants.