Regulatory Rapporteur October 2015

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Front Cover
Volume 12 Issue 10

In This Issue

  • FOCUS - Clinical trials
  • PLUS
  • Devices: A unified approach to unannounced audits
  • Interview: Prof Dr med Karl Broich, BfArM President

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Regulatory Rapporteur October 2015MembersFull Issue3MBPDF
Editorial: High hopes for better harmonisationPublic42KBPDF
The EU Clinical Trial Regulation – A regulator’s perspectivePublic72KBPDF
Clinical trial disclosure in the EU: Standards, legislation, policies and practicesMembers69KBPDF
Conducting a regulatory orchestra: Interview with Prof Dr med Karl Broich, President of BfArM,Members173KBPDF
The EMA policy on publication of clinical data: current statusMembers49KBPDF
The EU Clinical Trial Regulation: Are we ready for its implementation?Members71KBPDF
The impact of the new EU Clinical Trial Regulation on early phase clinical researchMembers68KBPDF
Unannounced audits – A notified body perspectiveMembers79KBPDF