Regulatory Rapporteur February 2004

<< back to list of Issues

Front Cover
Volume 1 Issue 2

In This Issue

  • Biogenerics: Development and regulatory hurdles
  • Parallel importation of devices in the EU
  • The Exchange: Your questions answered

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

Regulatory Rapporteur February 2004MembersFull Issue1MBPDF
New electronic submission rules in GermanyPublic79KBPDF
A message from Dr Axel F WenzelMembers72KBPDF
A short summary of major changes of regulatory interest occurring in Italy, introduced by Law 326/2003 and Financial Bill (Law 3Members65KBPDF
BIRA Biotech Workshop: Development geneticsMembers56KBPDF
BIRA Means Business: Working with personality and cultural differences: or…Knowing me, knowing youMembers70KBPDF
BIRA Regulatory Annual Review meetingMembers62KBPDF
Parallel importation of medical devices within the EUMembers139KBPDF
Review of the EU pharmaceutical legislation: EFPIA comment on outcome of the final vote by the European ParliamentMembers229KBPDF
Similar biological medicinal products – development and regulatory hurdlesMembers150KBPDF
The European Society of Regulatory Affairs (ESRA) Introductory Course: Target the heart of European Regulatory AffairsMembers50KBPDF