Regulatory Rapporteur June 2015

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Front Cover
Volume 12 Issue 6

In This Issue

  • FOCUS – Combination products
  • PLUS
  • Preparing submissions across the EU and US
  • Veterinary medicines: EMA/IFAH-Europe Info Day

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Regulatory Rapporteur June 2015MembersFull Issue2MBPDF
A European perspective and guide to key regulatory considerations for combination productsPublic206KBPDF
Editorial: new products, new challengesPublic43KBPDF
Combined advanced therapy medicinal products: European regulatory requirements, pathways and processesMembers69KBPDF
Interview with John (Barr) Weiner: Lawyer, regulator, policy makerMembers332KBPDF
Meeting report: 14th EGA Regulatory and Scientific Affairs ConferenceMembers58KBPDF
Meeting report: European Medicines Agency/IFAH-EuropeMembers69KBPDF
Meeting report: Joint Pharmaceutical and Analysis Group Symposium – Quality Risk Management: A Pragmatic ApproachMembers65KBPDF
Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2Members493KBPDF