Recent survey results show that the pharmaceutical companies often take an overly conservative approach to NIMPs (or Non-IMPs) due to regulatory and operational ambiguity. This can lead to unnecessary expenses and process steps, which can needlessly complicate clinical trials.
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.
This in-depth Guide will help you properly manage NIMPs by providing guidance on:
- Sourcing strategies
- Packaging and labeling approaches
- Storage and distribution recommendations
- Regulations categorized by region/country
- Approaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategy
- Regulatory differences between NIMPs and comparators
| File Size : | 1
file
, 2.1 MB |
| ISBN(s) : | 9781936379576 |
| Note : | This product is unavailable in Russia, Belarus |
| Number of Pages : | 56 |
| Published : | 01/01/2013 |
