Regulatory Rapporteur January 2005

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Front Cover
Volume 2 Issue 1

In This Issue

  • Gene therapy: myths and pitfalls
  • FDA guidelines on sterile drug products
  • New EU medicines legislation

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

TitleDownloadCategorySizeFile
Regulatory Rapporteur January 2005MembersFull Issue2MBPDF
Gene therapy: Myths, pitfalls and lessons to learnPublic202KBPDF
China: Timetable for medical device GMP complianceMembers182KBPDF
Conference on New EU Medicines LegislationMembers347KBPDF
EU Chemistry and Pharmacy regulatory procedures and requirements for Marketing Authorisation ApplicationsMembers121KBPDF
EU Regulatory Intelligence: Updates November – December 2004Members155KBPDF
FDA’s Guidance for Industry on sterile drug products produced by aseptic processing – current Good Manufacturing PracticeMembers164KBPDF
Maple Leaf NewsMembers176KBPDF
Pharmacokinetics: Intermediate courseMembers164KBPDF
The challenge of regulating gene therapyMembers130KBPDF
The Exchange: Co-ordinated by Origin Pharmaceutical Services LimitedMembers114KBPDF