Regulatory Rapporteur February 2006

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Front Cover
Volume 3 Issue 2

In This Issue

  • The role of immunoassays and bioassays
  • Impact of new pharamaceutical legislation
  • Pre-clinical challenges facing cell-based medicinal products

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Regulatory Rapporteur February 2006MembersFull Issue5MBPDF
The role of immunoassays and bioassays in biopharmaceutical development: an overview for regulatory specialistsPublic489KBPDF
BioIndustry Association Regulatory Affairs Advisory Committee Seminar – Are you prepared for the New EU Medicines Legislation?Members145KBPDF
EMEA/DIA Joint Workshop: EMEA new guidelines for development and approval of biosimilarsMembers201KBPDF
EU Regulatory Intelligence: Updates December 2005 – January 2006Members216KBPDF
Handbook of Biogeneric Therapeutic Proteins. Regulatory, Manufacturing, Testing, and Patent Issues*, Sarfaraz K. NiaziMembers97KBPDF
Impact of the new pharmaceutical legislation on the development and registration of biological medicinal products in the EUMembers270KBPDF
Portugal: Changes in the OTC market/ Reduced prices and profit margins for reimbursed drugsMembers167KBPDF
Pre-clinical challenges facing cell-based medicinal productsMembers152KBPDF
The dynamics and challenges of biopharmaceuticals and advanced therapiesMembers105KBPDF
The Exchange: Co-ordinated by Origin Pharmaceutical Services LimitedMembers319KBPDF