We wrote this Guide to address regulatory concerns about the way IRT is used for pharma, in an effort to establish industry standards and show the benefits that wide-spread adoption of IRT could have for the industry, and ultimately, for patients.
Tampa, Florida (PRWEB) December 13, 2011
ISPE announced today that it has released an important new title in its family of Guidance Documents: ISPE Good Practice Guide: Interactive Response Technology. This document breaks new ground describing how IRT can be used to leverage cGMP data and information to enhance compliance, efficiency, and patient safety in clinical trials. It is the pharmaceutical industry’s first guide on IRT, and the direction of the contents was influenced by concerns from regulators working for the European Medicines Agency (EMA).
The ISPE Good Practice Guide: Interactive Response Technology provides guidance to the pharmaceutical industry on how to successfully implement IRT to manage key clinical trial activities, particularly expiry date management and program pooling. The Guide also aims to help industry professionals communicate and foster a standardized industry-wide approach to critical functionality of IRT when used in managing Investigational Medicinal Product.
“Interactive Response Technology has the potential to enhance the efficiency of clinical trials while also reducing cost and enhancing patient safety,” said Mike Arnold, one of the Guide’s authors. “We wrote this Guide to address regulatory concerns about the way the technology is used, in an effort to establish industry standards and show the benefits that wide-spread adoption of IRT could have for the industry, and ultimately, for patients.”
The ISPE Good Practice Guide: Interactive Response Technology discusses how IRT can be used to improve consistency in managing dispensing activities at the study site, effectively manage drug accountability on the study site level and at the end of the clinical trial, manage site inventories, and more. It covers key concepts, roles and responsibilities in using IRT, as well as system fundamentals, considerations for in-house versus vendor-managed IRT systems, regulatory requirements, quality controls, warehousing and distribution, and monitoring of critical activities and associated risks.
For more information the ISPE Good Practice Guide: Interactive Response Technology, or to order an electronic copy, visit http://www.ISPE.org/ISPE-Good-Practice-Guides/Interactive-Response-Technology.
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit http://www.ISPE.org for additional Society news and information.