Investigational Medicinal Product (IMP)

Guidance Docs
Every year the number of clinical trials conducted across the globe rises in a concerted effort to develop new or improved medicinal products that ultimately improve lives. The pharmaceutical industry has developed standards and best practices in almost every aspect of a trial. There is, however, one area that lacks foundational best practices: that of medicinal product accountability, reconciliation, and return for destruction, otherwise known as reverse logistics.
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.
Guidance Docs
Published: March 2014 Pages: 118 Table of Contents Appendix 2 Special Pricing for Emerging Economies Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for
This three-part paper focuses on the final results from the EU and China Patient Perceptions of Investigational Medicinal Products surveys and compares some of these results with the original "ISPE Project Concerning Patient Experience with Clinical Trial Materials" published in 2013.
Guidance Docs
1 Introduction It is current practice to use booklet labels for labelling of Investigational Medicinal Products (IMPs) to be used in multinational...