is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
