Regulatory Rapporteur July/August 2009
Volume 6 Issue 7
In This Issue
- Regulatory principles and practices for advanced therapies
- Stem cell therapy regulations – US vs EU
- Somatic cell therapies – quality aspects of an IMPD
- Interview: Inside Sweden’s regulatory agency, the MPA
- A guide to Japan’s clinical trial consultation system
Please login to download articles. Non-members may download the Focus article.
| Title | Download | Category | Size | File |
|---|---|---|---|---|
| Regulatory Rapporteur July/August 2009 | Members | Full Issue | 4MB | |
| Articles | ||||
| The clinical trial consultation system in Japan | Public | International Focus | 319KB | |
| Advanced therapies: Regulatory principles and practice | Members | Focus | 101KB | |
| Editorial - Spotlight on advanced therapies | Members | General | 61KB | |
| EU Regulatory Intelligence: Updates during April – May 2009 | Members | European Focus | 99KB | |
| Quality aspects of an investigational medicinal product dossier for somatic cell therapies | Members | Focus | 93KB | |
| Stem cell therapy regulations - The US vs the EU | Members | Focus | 95KB | |
| Taking a global view - Interview with Dr Christina Åkerman, Director General of the Swedish Medical Products Agency | Members | General | 184KB | |
| The Exchange - Coordinated by Cambridge Regulatory Services Limited (CambReg) | Members | General | 62KB |
