Regulatory Rapporteur January 2010

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Front Cover
Volume 7 Issue 1

In This Issue

  • A paperless network in 2010? Migrating into PIM format - The promise of eCTD
  • Science-driven guidance for IMPDs
  • Good review practices in Canada
  • Medicinal product, or medical device?

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Regulatory Rapporteur January 2010MembersFull Issue3MBPDF
PIM – the EU’s planned default process for product information submission and managementPublic646KBPDF
A science-driven approach to IMPDs for radio-labelled drugs used in drug mass balance clinical studiesMembers683KBPDF
Contribute to Regulatory Rapporteur in 2010Members473KBPDF
EU Regulatory Intelligence: Updates during October–November 2009Members462KBPDF
Good review practices – CanadaMembers491KBPDF
Is Europe ready for eCTD? An industry perspectiveMembers830KBPDF
Strides towards a paperless EuropeMembers486KBPDF
The impact of the European Commission guideline MEDDEV 2.1/3 Revision 3Members517KBPDF
The Medical Devices ExchangeMembers468KBPDF