Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?

ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global 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 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand 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 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.

This audio conference covers:

• The scope of ISO 14155 and its elements
• How to integrate ISO 14155 into US-based quality systems
• Similarities with the GHTF, ICH and ISO standards for clinical trial activities
• Systems and tools to manage the conduct of clinical trials to meet the required elements of ISO 14155:2011
• Tips to integrate the revised standard into clinical trial standards globally

About the speaker:

Joy Frestedt, PhD, RAC, CCTI is President & CEO of Frestedt Incorporated, a novel virtual network with 50 experts meeting client needs in regulatory, clinical and quality affairs. Dr. Frestedt has 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical, medical device and food industries including work at University of Minnesota, Mayo Clinical Trial Services, Johnson and Johnson, AstraZeneca, Orphan Medical, CNS Therapeutics, Medtronic and others. Dr. Frestedt holds a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of ASCO, AAPS, ACRP and she currently Chairs the Ethics Committee for the Regulatory Affairs Professionals Society.

Who should attend?

• VP, Director, Manager Clinical Operations
• VP, Director, Manager Regulatory Affairs
• VP, Director, Manager Medical Affairs
• VP, Director, Manager of Quality
• Health & Safety
• Engineering