Regulatory Rapporteur October 2014

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Front Cover
Volume 11 Issue 10

In This Issue

  • FOCUS - Innovation
  • PLUS
  • Trial master files: Avoiding inspection blues
  • Is your device a laser product, and is it compliant?

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Regulatory Rapporteur October 2014MembersFull Issue2MBPDF
Editorial: New frontiersPublic48KBPDF
The EU Clinical Trial Regulation: What’s on the horizon, and what can sponsors do to prepare? Part 1 – Authorisations, substantial modifications and ITPublic106KBPDF
Biological qualifiers – a WHO proposal for unique biosimilar INNs?Members89KBPDF
From biomarkers to personalised medicines: Opportunities, challenges and the proposed EU IVD Regulation – Part 2Members107KBPDF
Interview: Uniting strategy and scienceMembers85KBPDF
Laser product compliance for medical devices in a global marketMembers108KBPDF
Meeting report: ICR Ethics and GCP Forum – Risk-based study managementMembers68KBPDF
Meeting report: MHRA Good Pharmacovigilance Practice SymposiumMembers113KBPDF
Planning for successful IDMP implementationMembers105KBPDF
Planning for successful IDMP implementationMembers105KBPDF