Regulatory Rapporteur March 2015

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Front Cover
Volume 12 Issue 3

In This Issue

  • FOCUS - Japan's regulatory environment
  • PLUS
  • PMDA consultation meetings
  • Japan’s SAKIGAKE initiative
  • Nonclinical safety assessment
  • Medical devices regulation

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Regulatory Rapporteur March 2015MembersFull Issue5MBPDF
Editorial: Japan’s “safety triangle” makes sweet musicPublic40KBPDF
Japan: Key considerations for successful PMDA consultation meetingsPublic273KBPDF
Advanced therapy medicinal products: how to bring cell-based medicinal products successfully to the marketMembers56KBPDF
An update on the regulation of medical devices in JapanMembers87KBPDF
Analytical comparability: Methods and strategies for biologics, biosimilars & biobettersMembers168KBPDF
Japan’s emissary to EuropeMembers214KBPDF
Options in regulatory affairs – specialties and skill setsMembers87KBPDF
Regulatory aspects of nonclinical drug development in JapanMembers71KBPDF
The Annual EMA Review of the Year and Outlook for 2015Members65KBPDF
The Veterinary Medicines ExchangeMembers55KBPDF