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Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines
Session Chair(s)
Magda Bujar, PhD, MSc
Senior Manager, Regulatory Programme and Strategic Partnerships
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
This session illustrates how implementation of decision science and quality decision-making practices can improve transparency and accountability, minimise bias and ultimately enable better processes for cross-functional company and agency teams.
Learning Objective : Discuss how to increase the awareness of decision science including types of biases and potential solutions for teams; Describe tools for assessing the quality of decision-making practices, ensuring their implementation and documentation; Illustrate experiences from a company and an agency on the practical application of such approaches to enhance decision transparency and accountability across teams.
Speaker(s)
Regulatory Agency Viewpoint: Update on HPFB Regulatory Decision Guide
Marilena Bassi, MA
Health Canada, Canada
Senior Executive Director, Therapeutic Products Directorate
Decision Quality in the Pharmaceutical Industry: Successes and Opportunities - The Industry Point of View
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
Decision Professional Viewpoint
Carl Spetzler, PhD
Strategic Decisions Group, United States
Chief Executive Officer
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