Regulatory Rapporteur February 2014

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Front Cover
Volume 11 Issue 2

In This Issue

  • FOCUS: Middle East and Africa
  • PLUS
  • Benefit–risk assessment
  • US & EU submission planning
  • Veterinary pharmacovigilance

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Regulatory Rapporteur February 2014MembersFull Issue1MBPDF
Current challenges in the South African post-approval CMC landscapePublic146KBPDF
Editorial - Africa and the Middle East: Two regions united by their diversityPublic47KBPDF
Exploring your regulatory path in the Middle East and Africa regionMembers190KBPDF
Israel and Turkey: A comparison of clinical trial and regulatory landscapes in two key Middle East marketsMembers113KBPDF
Maple Leaf News – Update from CanadaMembers60KBPDF
Practical application of benefit–risk assessmentMembers220KBPDF
Transatlantic Planning: Using eCTD format US INDs as a planning and preparation tool for EU MAAsMembers125KBPDF
Veterinary pharmacovigilance inspections and audits: Part 1 – What might be audited or inspected?Members108KBPDF