ISPE, the International Society for Pharmaceutical Engineering, has issued guidance to help companies conducting clinical trials in multiple countries standardize their use of booklet labels. The Guide provides templates, guidelines, and tools to make it easier for companies to use booklet labels consistently and effectively and justify their booklet label methods to international regulatory authorities.
“ISPE is pleased to introduce its first Guide to support harmonization of labeling requirements globally,” says ISPE president and CEO Nancy S. Berg. “Companies involved in clinical trials now have a resource that provides guidance on how to design and structure a booklet label and how to standardize the use and application of booklet labels for global clinical trials. By following the recommendations presented in the Guide, companies can feel confident that their booklet label strategy is supported by a scientific, risk-based methodology and patients are receiving accurate, complete instructions in their local language.”
The ISPE Good Practice Guide: Booklet Labels has been reviewed by MHRA officials, and their feedback has been incorporated into the Guide’s content. The Guide’s recommendations will help companies determine the gaps between their current booklet label procedures and best practices. It contains resources for training clinical trial personnel on proper booklet label use and templates that companies can put into practice immediately to help improve compliance and cost-effectiveness of their clinical trials.
ISPE is a not-for-profit association serving its members through leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, FL, and offices in Brussels, Belgium, Singapore, and Shanghai, China.