Regulatory Rapporteur February 2019

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Front Cover
Volume 16 Issue 2

In This Issue

  • FOCUS - ATMPs
  • PLUS
  • CMC section of an EU IMPD: advice for US sponsors

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TitleDownloadCategorySizeFile
Regulatory Rapporteur February 2019MembersFull Issue4MBPDF
Editorial: Advancing advanced therapiesPublic37KBPDF
Interview: Helping to bring ATMPs to the marketPublic72KBPDF
CAT interested parties meeting – recent developments and updatesMembers143KBPDF
Design and optimisation of a quality target product profile for ATMPsMembers71KBPDF
Expedited access of cellular and gene therapy products: The EU versus the USMembers94KBPDF
The CMC section of an EU IMPD: Considerations for US sponsorsMembers64KBPDF
The SAKIGAKE framework for regenerative medicines in JapanMembers59KBPDF