Quality Management in Clinical Research: A Matter of Human Rights

A sound Quality Management System is the underpinning of true human subject protection in clinical research. Research ethics committees are charged with protecting the rights and welfare of research participants and, along with regulatory agencies, ensuring that research sponsors and investigators meet their responsibilities to the research enterprise, which can only be realized through understanding and adopting appropriate measures to ensure quality in every aspect of the clinical trial. Only by understanding the theory and application of quality systems and their foundations with measurable outcomes can successful design and implementation of meaningful QMS be achieved.

The presenters for this webinar are leaders in their respective fields. Marianne Vanderwel will give a brief history of quality, describe some quality principles, and lead to the ISO diagram of quality oversight. Pierre Deschamps will describe how the integration of quality principles has catapulted Toyota into a global quality leader in their industry, and how such integration is essential to improving the delivery of quality health services including health research.

Speakers

Pierre Deschamps, C.M., Ad. E., Adjunct Professor, Faculty of Law, McGill University

Pierre Deschamps graduated in Law from McGill University after obtaining a degree in Religious Studies from the Université de Montréal. He was, for 10 years, a member of the Canadian Human Rights Tribunal and Associate Director of Research (Law and Health Section) at McGill University’s Research Centre in Private and Comparative Law. He also held for 20 years an appointment as an Adjunct Professor at the McGill Faculty of Law where he taught tort law as well as the law of persons and human rights. In 2000, Mr. Deschamps was made a member of the Order of Canada for his work with children suffering from cancer and his seminal report of control mechanisms with regard to research activities. Me Deschamps has had a long standing interest in Deming’s seminal work on quality and in adapting the Toyota Way’s foundational quality principles of respect and continuous improvement to clinical research.

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Marianne Vanderwel, MEng, MSc, Director, Human Research Protection Program, IRB Services

Ms. Marianne Vanderwel is the Director, Human Research Protection Program at Institutional Review Board Services. She holds Master’s degrees in Engineering Physics and in Medical Sciences from McMaster University. After 10 years of academic research in health sciences, she moved to the healthcare industry in 1987 where she held various positions in diagnostic research and clinical research. From 1993 to 2007, Marianne worked in the area of quality management for major Pharmaceutical companies with oversight responsibilities related to Good Clinical Practices and pharmacovigilance in Canada and worldwide. Since 2007, she is responsible for maintaining an effective Human Research Protection Program at Institutional Review Board Services. Marianne extends her role to the research community by actively participating in industry, academic and regulatory authority collaborations.

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