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DIA 2021 Global Annual Meeting

Culture of Quality: A Competitive Advantage

Session Chair(s)

Leslie  Sam

Leslie Sam

  • President
  • Leslie Sam and Associates, United States
ICH E8(R1) requires sponsors to “Create a culture that values and rewards critical thinking and open dialogue”. This session provides strategic and tactical approaches for optimizing an organization’s culture of quality and critical thinking approaches.
Learning Objective : Summarize the state of research and development culture of quality; Recognize culture of quality values, behaviors, traditions; Describe phases for optimizing culture of quality; Describe critical thinking and why it is important to a quality culture; Explain the critical thinking 4As framework; Describe a maturity model for developing critical thinking skills focused on drug development.


Michael  Torok, PhD

Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture

Michael Torok, PhD

  • Senior Director, Clinical Quality Assurance
  • Astellas, United States
Jennifer  Martin

Regulators Perspective on the Value of a High Performing Culture of Quality in Clinical Trial Research

Jennifer Martin

  • GCP Operations Manager and Lead Senior GCP Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom