Regulatory Rapporteur September 2018

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Front Cover
Volume 15 Issue 9

In This Issue

  • FOCUS - Chemistry, Manufacturing and Controls
  • Plus
  • Professional development in regulatory affairs
  • Paediatric studies: advancing child health?

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Regulatory Rapporteur September 2018MembersFull Issue7MBPDF
Editorial: The evolution of qualityPublic37KBPDF
The MHRA approach to data integrityPublic372KBPDF
Accelerated pathways: CMC considerationsMembers71KBPDF
Deconstructing the revised EMA guideline on manufacture of the finished dosage formMembers70KBPDF
FDA/EMA-triggered paediatric studies: Do they really advance child health?Members77KBPDF
Using professional development to attract and retain talentMembers154KBPDF
Where does drug substance manufacture end and drug product manufacture begin?Members79KBPDF
Why professional development is more important than ever in regulatory affairsMembers62KBPDF