Regulatory Rapporteur June 2013

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Front Cover
Volume 10 Issue 6

In This Issue

  • FOCUS - Regulatory resources & management
  • PLUS
  • The value of observational studies
  • A quantum leap in diagnostics legislation
  • Benefits of PAT-based submissions
  • Veterinary sector developments

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Regulatory Rapporteur June 2013MembersFull Issue3MBPDF
Editorial: Intelligent and efficient regulatory resourcingPublic90KBPDF
Good decision-making practice in the regulatory arenaPublic87KBPDF
Applications of real world evidence in the regulatory processMembers133KBPDF
Current trends in the regulatory resourcing landscapeMembers177KBPDF
How to effectively resource for regulatory affairs functionsMembers89KBPDF
Meeting report: EMA/IFAH-Europe Info DayMembers62KBPDF
Modern document management: The content of technical solutions seen in the context of regulatory useMembers96KBPDF
Process analytical technology: Experiences with PAT-based submissionsMembers104KBPDF
The draft in vitro diagnostic regulation – revolution not evolutionMembers160KBPDF