Regulatory Rapporteur November 2016

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Front Cover
Volume 13 Issue 11

In This Issue

  • FOCUS - North America
  • PLUS
  • Proposals for new veterinary medicines legislation
  • Views on the effectiveness of risk minimisation tools

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Regulatory Rapporteur November 2016MembersFull Issue2MBPDF
Editorial: Reviewing new US regulatory standardsPublic164KBPDF
US regulatory compliance with the standard for exchange of nonclinical data (SEND)Public230KBPDF
Efficient drug development for promising medicines: US and EU regulatory toolsMembers278KBPDF
Effectiveness of post authorisation safety studies and risk minimisation measures in EPARS: Part 1Members259KBPDF
Interview: Starting small, thinking bigMembers217KBPDF
Meeting report: Redrafted proposals for EU regulations on VMPs and medicated feedingstuffsMembers209KBPDF
Meeting report: Regulatory audits across borders: How US and EU regulators cooperateMembers201KBPDF
The updated US eCTD Module 1: Review and analysisMembers231KBPDF