Regulatory Rapporteur November 2008

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Front Cover
Volume 5 Issue 11

In This Issue

  • A meeting of minds: the burgeoning relationship between the US and EU orphan drug agencies
  • Patient power: inside Eurordis, the European organisation representing rare disease patients
  • A guide to orphan product pre-launch requirements in the EU

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Regulatory Rapporteur November 2008MembersFull Issue2MBPDF
Orphan designation in the EU: An overview and key achievementsPublic420KBPDF
Editorial - Orphan drugs: Making the unappealing appealingMembers43KBPDF
EU Regulatory Intelligence: Updates September to October 2008Members43KBPDF
Focus Interview - A meeting of minds Members88KBPDF
Orphan products: Pricing, reimbursement and supplementary pre-launch requirements in the EUMembers92KBPDF
Rare disease patient representatives in the EU orphan drug environmentMembers150KBPDF
The Exchange - Co-ordinated by Cambridge Regulatory Services Limited (CambReg)Members80KBPDF
The pharmacist and Good Drug Distribution Practice in EuropeMembers56KBPDF
The regulatory framework for over-the-counter medicinal products - Part II: CEE procedures, requirements and safety concernsMembers291KBPDF