Regulatory Rapporteur February 2016

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Front Cover
Volume 13 Issue 2

In This Issue

  • FOCUS - Early access to medicines
  • PLUS
  • Advice for small and medium-sized enterprises
  • The new functionality of the PSUR repository
  • Interview: Anja Holm, CVMP Chair

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Regulatory Rapporteur February 2016MembersFull Issue2MBPDF
Editorial - The STAMP of approval for early access to new drugsPublic35KBPDF
The importance of early access to medicines for patients suffering from rare diseasesPublic64KBPDF
A regulator’s guide to the UK Early Access to Medicines SchemeMembers201KBPDF
A regulator’s insights for SMEs in the biologics and advanced therapies sectorsMembers64KBPDF
For ill creatures great and small: interview with Anja HolmMembers122KBPDF
PSUR repository – Interactive Q&A sessionMembers173KBPDF
Therapeutic product access and expedited review pathways in North AmericaMembers130KBPDF