Regulatory Rapporteur April 2013

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Front Cover
Volume 10 Issue 4

In This Issue

  • FOCUS - Advanced Therapies
  • PLUS
  • Case study: first vaccine approval via Article 58
  • A review of biosimilar monoclonals guidance
  • Regulators’ recommendations on scientific advice

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Regulatory Rapporteur April 2013MembersFull Issue2MBPDF
First-in-human clinical studies: challenges to ATMPsPublic593KBPDF
Advanced therapy medicinal products for whom? The different facets of hospital exemptionMembers483KBPDF
Advancing the case of new therapiesMembers486KBPDF
Obtaining scientific advice from the regulators - the good, the bad and the uglyMembers492KBPDF
The European Medicines Agency's Article 58 procedure: reflections on the first approval for a vaccineMembers619KBPDF
The evolution of EU biosimilar monoclonal antibody guidanceMembers528KBPDF