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DTSTAMP:20260419T145154Z
DTSTART:20230602T124000Z
DTEND:20230602T134500Z
SUMMARY:Plenary session five - A global look at expedited programmes for 
 drug and device development
DESCRIPTION:Expedited programs such as accelerated approval has been a cr
 itical tool to get promising new treatments to patients more quickly and
  have been the subject matter of an EU legislative proposal. However\, s
 uch programs are increasingly a source of controversy\, with new pressur
 es emerging with respect to the trade-offs associated with residual unce
 rtainties in approvals based on certain biomarkers or clinical endpoints
 \, the costs of such products\, the speed of confirmation of effectivene
 ss via post-market clinical trials\, and the use of real-world evidence 
 to support such confirmation. This panel will take a comparative look at
  such expedited programs and examine these evolving regulatory and legal
  issues.\n
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