Regulatory Rapporteur July/August 2014

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Front Cover
Volume 11 Issue 7

In This Issue

  • FOCUS - Chemistry, Manufacturing & Controls
  • PLUS
  • Lean stability strategies
  • Can GMP lead to drug shortages?
  • Challenges of mixed or co-processed excipients

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Regulatory Rapporteur July/August 2014MembersFull Issue2MBPDF
Editorial: Tackling quality challengesPublic46KBPDF
Meeting report: "One stop shop": Understanding the Early Access to Medicines SchemePublic153KBPDF
Regulatory responses to the use of various lean stability strategies in early drug developmentPublic95KBPDF
An overview of the regulatory procedures and requirements in Ukraine and Russia: Part 2 - RussiaMembers68KBPDF
Challenges when registering a mixed or co-processed excipientMembers75KBPDF
Considerations for due diligence for pharmaceutical productsMembers192KBPDF
Examining the link between good manufacturing practice and drug shortagesMembers85KBPDF
From Bible to EU Regulation: A brief history of the clinical trialMembers70KBPDF
Meeting report: Bangalore INDIA BIO 2014Members87KBPDF
Regulatory uncertainty vs legislative inevitability: A global perspective on pressures and pathways for biosimilarsMembers111KBPDF