Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional teams must exhibit high performing Cultures of Quality. He has widely lectured on team dynamics including Critical Thinking and Open Proactive Dialog to enhance Risk Based Quality Management. Michael has held senior leadership roles in Quality, Operations, and Outsourcing, and holds a Ph.D. in Biochemistry and Molecular Genetics from the University of Virginia School of Medicine.

With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by the industry organization, TransCelerate, to co-develop and co-author a conceptual clinical quality management system framework and issue management framework. She was also a reviewer of the TransCelerate conceptual risk management framework. She leverages her depth of understanding of industry leading practices and regulatory guidance to define and apply strategic and tactical risk-based approaches to clinical trial implementation. practices.