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.

This audio conference covers:

• The establishment of a system to update SOPs
• The establishment of a system to regularly review FDA and EU (and other territory) regulations and guidance
• Review updates and new guidance against current SOPs and WPDs
• How to systematically make sure that all the changes are captured in revised SOPs and WPDs
• A list of the main changes in the ISO 14155 standard that may necessitate changes to SOPs/WPDs
• Training related to the changes, and how to check that the updated SOPs are working well

About the speaker:

Helen Colquhoun is CEO of Pleiad Inc, a full-service medical device CRO. She has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts.

Who should attend?

• Regulatory Specialists
• Quality Specialists
• Clinical Trial Managers