Regulatory Rapporteur January 2016

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Front Cover
Volume 13 Issue 1

In This Issue

  • FOCUS – Best practices in regulatory documentation
  • PLUS
  • IDMP: Moves towards regulatory compliance
  • Evaluating risk management materials
  • Nonclinical initiatives for line extensions

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Regulatory Rapporteur January 2016MembersFull Issue3MBPDF
Editorial - Document preparation: Bridging the gapsPublic46KBPDF
Managing procedures for the marketplace: interview with Anne-Marie van NederKasselPublic62KBPDF
Considerations for repurposing legacy regulatory documentationMembers199KBPDF
Effectiveness evaluatedMembers126KBPDF
ICH revisions for benefit–risk assessmentMembers700KBPDF
IDMP: An opportunity for information integration across the pharmaceutical value chainMembers216KBPDF
Managing regulatory divergence in non-ICH countriesMembers199KBPDF
Nonclinical strategy and solutions for drug line-extension developmentMembers65KBPDF