Regulatory Rapporteur July/ August 2005
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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| Title | Download | Category | Size | File |
|---|---|---|---|---|
| Regulatory Rapporteur July/ August 2005 | Members | Full Issue | 2MB | |
| Formulating a development programme for a biosimilar medicinal product | Public | 131KB | ||
| A new regulatory landscape | Members | 75KB | ||
| Assessment of products based on accelerated clinical development and limited data packages | Members | 89KB | ||
| BioIndustry Association Regulatory Affairs Advisory Committee Seminar | Members | 75KB | ||
| CRED Biotechnology meeting Non-clinical and clinical testing of biotechnology products | Members | 190KB | ||
| CRED Workshop The evolving pharmaceutical dossier, active drug substance | Members | 118KB | ||
| EU Regulatory Intelligence: Updates May – July 2005 | Members | 112KB | ||
| Japan: Pharmaceutical and Medical Devices Agency (PMDA) resumes consultation | Members | 72KB | ||
| Regulatory approvals for oncology products based on accelerated clinical development and limited data packages – 2 | Members | 183KB | ||
| The Exchange: Co-ordinated by Origin Pharmaceutical Services Limited | Members | 142KB |