Regulatory Rapporteur May 2004

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Front Cover
Volume 1 Issue 5

In This Issue

  • Brussels and London launch for TOPRA
  • Gaining orphan status in the EU
  • Clinical Trials Directive after May 1st

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Regulatory Rapporteur May 2004MembersFull Issue2MBPDF
The official launch of TOPRAPublic896KBPDF
Business as usual – Fast approvals for Phase I after May 1, 2004?Members51KBPDF
CRED: Biotechnology – Proteins as biopharmaceuticalsMembers66KBPDF
European Commission reorganisation of the non-food scientific advisory committeesMembers90KBPDF
Japan: New regulatory agency establishedMembers94KBPDF
The Clinical Trials Directive (2001/20/EC) – problems with implementationMembers650KBPDF
TOPRA North Discussion Forum: Implementation of the Clinical Trials Directive – an industry perspectiveMembers60KBPDF