• Available Formats
    • Availability
    • Priced From ( in USD )
    • Secure PDF

      Secure PDF Files

      Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.

        What you can do with a Secure PDF:
      • Print
      • Search
      • Highlight
      • Bookmark
      Please note that some publishers - including BOMA, IADC and ICML - do not allow printing of their documents.

    • Immediate download
    • $410.00
    • Add to Cart

About This Item


Full Description

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