Regulatory Rapporteur February 2015

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Front Cover
Volume 12 Issue 2

In This Issue

  • FOCUS - Orphan drugs
  • PLUS
  • Clinical trial transparency under review
  • Parallel or sequential EU/US dossier preparation?

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Regulatory Rapporteur February 2015MembersFull Issue946KBPDF
Editorial: Orphan drugs for orphan diseases – challenges and hurdlesPublic39KBPDF
Orphan medicinal products – A European process overviewPublic155KBPDF
1st International Medtech & Pharma Conference: Innovation at the interfaceMembers81KBPDF
Challenges in benefit–risk assessment of orphan drugsMembers110KBPDF
Interview: A guardian of Germany’s veterinary interestsMembers76KBPDF
Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1Members60KBPDF
The realities of clinical trial transparency: Part 1Members57KBPDF