Regulatory Rapporteur May 2015

<< back to list of Issues

Front Cover
Volume 12 Issue 5

In This Issue

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

Please login to view member only articles. Non-members may download the public articles.

TitleDownloadCategorySizeFile
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