Regulatory Rapporteur March 2015
Volume 12 Issue 3
In This Issue
- FOCUS - Japan's regulatory environment
- PLUS
- PMDA consultation meetings
- Japan’s SAKIGAKE initiative
- Nonclinical safety assessment
- Medical devices regulation
Please login to view member only articles. Non-members may download the public articles.
| Title | Download | Category | Size | File |
|---|---|---|---|---|
| Regulatory Rapporteur March 2015 | Members | Full Issue | 5MB | |
| Editorial: Japan’s “safety triangle” makes sweet music | Public | 40KB | ||
| Japan: Key considerations for successful PMDA consultation meetings | Public | 273KB | ||
| Advanced therapy medicinal products: how to bring cell-based medicinal products successfully to the market | Members | 56KB | ||
| An update on the regulation of medical devices in Japan | Members | 87KB | ||
| Analytical comparability: Methods and strategies for biologics, biosimilars & biobetters | Members | 168KB | ||
| Japan’s emissary to Europe | Members | 214KB | ||
| Options in regulatory affairs – specialties and skill sets | Members | 87KB | ||
| Regulatory aspects of nonclinical drug development in Japan | Members | 71KB | ||
| The Annual EMA Review of the Year and Outlook for 2015 | Members | 65KB | ||
| The Veterinary Medicines Exchange | Members | 55KB |