is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, June 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.
This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.
Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.
