Regulatory Rapporteur September 2009

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Front Cover
Volume 6 Issue 9

In This Issue

  • The new classifications
  • CMD(h) expectations
  • A new legal framework
  • PLUS:
  • Quality by design – the role of the CMC professional
  • Regulatory update on Canada

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Regulatory Rapporteur September 2009MembersFull Issue4MBPDF
Better regulation of medicinal products: The new legal framework for variationsPublic513KBPDF
CMD(h) expectations of the revised variation regulationMembers532KBPDF
Editorial: Aspects of variations legislationMembers494KBPDF
EU Regulatory Intelligence: Updates May – June 2009Members614KBPDF
On the comparison of the current EU variations classification system and the proposed new systemMembers578KBPDF
That was the year that was – reflections on my year as TOPRA PresidentMembers473KBPDF
The Exchange - Coordinated by Cambridge Regulatory Services Limited (CambReg)Members470KBPDF
The role of the regulatory CMC professional in the quality-by-design paradigmMembers702KBPDF
Update from Canada - Maple Leaf NewsMembers500KBPDF