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Wednesday, June 17 • 4:00pm - 5:00pm
#340 SL: Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-683-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166IGDVAV; RN 1.00

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 Objectives

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.

Chair

Magda Bujar, PhD, MSc

Speaker

Regulatory Agency Viewpoint: Update on HPFB Regulatory Decision Guide
Marilena Bassi, MA

Pharmaceutical Company Viewpoint
Jeremy Jokinen, PhD, MS

Decision Professional Viewpoint
Carl Spetzler, PhD



Speakers
avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre For Innovation In Regulatory Science (CIRS)
Dr Magda Bujar is the Manager of Strategic Development at CIRS. In her current role, she is responsible for developing and executing strategies for engaging with CIRS stakeholders - pharmaceutical companies as well as major regulatory authorities. Magda also initiates and coordinates... Read More →
avatar for Marilena Bassi

Marilena Bassi

Senior Executive Director, Therapeutic Products Directorate, Health Canada
Marilena Bassi has been with Health Canada since 2004 where she has held various policy, evaluation and performance management related positions. Currently she is the Senior Executive Director of the Therapeutic Products Directorate at Health Canada.
avatar for Jeremy Jokinen

Jeremy Jokinen

Head of Business Capabilities and Innovation, Worldwide Patient Safety, Bristol-Myers Squibb Company
Jeremy is the Head, Business Capabilities and Innovation, Worldwide Patient Safety, for Bristol-Myers Squibb. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early... Read More →
avatar for Carl Spetzler

Carl Spetzler

Chief Executive Officer, Strategic Decisions Group
Dr. Spetzler has developed creative business strategies for major financial institutions, capital-intensive companies, high-technology manufacturers, and systems businesses. Dr. Spetzler works with top management and boards of directors to improve the risk-informed decision making... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session