Regulatory Rapporteur May 2015

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Front Cover
Volume 12 Issue 5

In This Issue

  • FOCUS - Advanced therapies
  • PLUS
  • Global biosimilars development
  • Harmonising stability requirements
  • Packaging in the veterinary arena

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Regulatory Rapporteur May 2015MembersFull Issue2MBPDF
Editorial: Advancing the future of therapeutics – ATMPsPublic38KBPDF
Challenges in the global clinical development of biosimilar productsMembers72KBPDF
Championing the advanced route: interview with Paula SalmikangasMembers104KBPDF
Development Pathways for Advanced Therapy Medicinal Products WorkshopMembers48KBPDF
Joint Pharmaceutical and Analysis Group meeting: Stability Challenges Part IIMembers62KBPDF
Measurement reliability over the cellular therapeutic product lifecycleMembers66KBPDF
MHRA Variations Seminar – Composite Coordinated Collections, a β€˜one-stop-shop’Members45KBPDF
The challenges of potency assay development for cell-based medicinal products in EuropeMembers91KBPDF
Why do we need a Guideline on Nordic Packages?Members49KBPDF