Regulatory Rapporteur July/ August 2005

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Front Cover
Volume 2 Issue 7

In This Issue

  • Development programme for a biosimilar medicinal product
  • User testing of Package Leaflets
  • XML language

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TitleDownloadCategorySizeFile
Regulatory Rapporteur July/ August 2005MembersFull Issue2MBPDF
Formulating a development programme for a biosimilar medicinal productPublic131KBPDF
A new regulatory landscapeMembers75KBPDF
Assessment of products based on accelerated clinical development and limited data packagesMembers89KBPDF
BioIndustry Association Regulatory Affairs Advisory Committee SeminarMembers75KBPDF
CRED Biotechnology meeting Non-clinical and clinical testing of biotechnology productsMembers190KBPDF
CRED Workshop The evolving pharmaceutical dossier, active drug substanceMembers118KBPDF
EU Regulatory Intelligence: Updates May – July 2005Members112KBPDF
Japan: Pharmaceutical and Medical Devices Agency (PMDA) resumes consultationMembers72KBPDF
Regulatory approvals for oncology products based on accelerated clinical development and limited data packages – 2Members183KBPDF
The Exchange: Co-ordinated by Origin Pharmaceutical Services LimitedMembers142KBPDF