Regulatory Rapporteur July/August 2009

<< back to list of Issues

Front Cover
Volume 6 Issue 7

In This Issue

  • Regulatory principles and practices for advanced therapies
  • Stem cell therapy regulations – US vs EU
  • Somatic cell therapies – quality aspects of an IMPD
  • Interview: Inside Sweden’s regulatory agency, the MPA
  • A guide to Japan’s clinical trial consultation system

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

Regulatory Rapporteur July/August 2009MembersFull Issue4MBPDF
The clinical trial consultation system in JapanPublic319KBPDF
Advanced therapies: Regulatory principles and practiceMembers101KBPDF
Editorial - Spotlight on advanced therapiesMembers61KBPDF
EU Regulatory Intelligence: Updates during April – May 2009Members99KBPDF
Quality aspects of an investigational medicinal product dossier for somatic cell therapiesMembers93KBPDF
Stem cell therapy regulations - The US vs the EUMembers95KBPDF
Taking a global view - Interview with Dr Christina Åkerman, Director General of the Swedish Medical Products AgencyMembers184KBPDF
The Exchange - Coordinated by Cambridge Regulatory Services Limited (CambReg)Members62KBPDF