Regulatory Rapporteur April 2006

<< back to list of Issues

Front Cover
Volume 3 Issue 4

In This Issue

  • Future regulation of Advanced Therapy Produ
  • Interview with Dr pekka Kurki
  • User testing of PILs
  • Regulatory Intelligence Update

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

TitleDownloadCategorySizeFile
Regulatory Rapporteur April 2006MembersFull Issue6MBPDF
Implementation of article 126(a) of Directive 2004/27/EC Medicines (Marketing Authorisation) Regulations – Qualified LicencesPublic176KBPDF
CRED Workshop: Biotechnology: Proteins as biopharmaceuticalsMembers185KBPDF
Delivering quality in PIL user testingMembers229KBPDF
EU Regulatory Intelligence: Updates February–March 2006Members242KBPDF
European Generics Association (EGA) - Fifth annual regulatory affairs conference: Time of changesMembers111KBPDF
Interview: Pekka KurkiMembers169KBPDF
Maintaining the flow of informationMembers96KBPDF
Management Forum - EU medicines legislation review 2005: the new routes to regulatory approval in EuropeMembers110KBPDF
Maple Leaf News – Update from CanadaMembers123KBPDF
Paperless submissions encouragedMembers152KBPDF