Regulatory Rapporteur October 2013

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Front Cover
Volume 10 Issue 10

In This Issue

  • FOCUS - Pharmacovigilance
  • PLUS
  • Biosimilars in the Latin American environment
  • Improving outcomes for paediatric patients
  • Innovation in drug development and regulation

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Regulatory Rapporteur October 2013MembersFull Issue2MBPDF
Editorial: The new PV legislation - the end of the beginningPublic56KBPDF
The EU Pharmacovigilance Risk Assessment Committee: First year experiencesPublic78KBPDF
6th Annual MHRA paediatric seminar: improving outcomesMembers277KBPDF
Innovation in the development and regulation of biopharmaceuticalsMembers406KBPDF
Prospects of biosimilars marketing within Latin-American countries under foreign exchange control policiesMembers505KBPDF
The impact of the changes to the PSUR legislationMembers115KBPDF
The new pharmacovigilance legislation, one year on – A national perspectiveMembers80KBPDF
The Pharmaceutical Package, one year on – Experiences of a national competent authorityMembers128KBPDF
The XEVMPD, one year on – An industry viewpointMembers119KBPDF