Regulatory Rapporteur November 2014

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Front Cover
Volume 11 Issue 11

In This Issue

  • FOCUS - North America
  • PLUS
  • An interview with Axel Thiele, BfArM
  • The EU Clinical Trial Regulation

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Regulatory Rapporteur November 2014MembersFull Issue13MBPDF
Editorial: Strategy in motionPublic3MBPDF
FDA Advisory Committee Meetings: What they are, why they happen, and what they mean for regulatory professionalsPublic125KBPDF
A 10-year timeline of US regulatory milestonesMembers87KBPDF
An introduction to value dossiers for early benefit assessment in Germany - Part 1: Processes and playersMembers541KBPDF
Health technology assessment processes in CanadaMembers494KBPDF
Interview: Putting safety firstMembers90KBPDF
Meeting report: ISCT Anniversary Meeting - Global regulatory perspectives on cell therapy developmentMembers69KBPDF
The EU Clinical Trial Regulation: What's on the horizon, and what can sponsors do to prepare? Part 2 - Additional provisionsMembers95KBPDF
The Rutgers Pharmaceutical Industry Fellowship program: further insightsMembers86KBPDF