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Monday, June 27 • 10:45am - 12:00pm
#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

The adoption of quality by design principles and subsequent incorporation of enhanced approaches in regulatory submissions introduced several challenges for industry as well as regulators. This session will discuss how the principles described in ICH Q9 are applied, specifically how quality risks are assessed, managed, and communicated by industry and evaluated by regulators and how results from risk assessments are used to determine quality criteria for demonstrating control and developing and maintaining a robust control strategy for a product.

Learning Objectives

Describe how quality risks are assessed, managed, and communicated by industry; Discuss how quality risks are evaluated by regulators.

Chair

Kristin Murray, MS

Speaker

Benefit-Risk Considerations and Strategies for Investigation and Control of Impurities
David White

Risk Management: A Team Sport
Wendy Wilson-Lee, BSN, PhD

Applications of Risk Management Tools to Quality by Design and Control Strategy Creation in Rare Disease
Joseph Kauten



Chair
KM

Kristin Murray

Director, Global CMC Regulatory Affairs, Shire Pharmaceuticals
Kristin Murray, MS, BS - Ms. Murray is a director in the Global Regulatory Affairs CMC department and oversees a team who manage global regulatory CMC submissions for both investigational and commercial products at Shire Pharmaceuticals, Lexington, MA. Before her tenure in regulatory affairs, Ms. Murray was a manager of a bioanalytical laboratory at Wyeth Pharmaceuticals, overseeing clinical, nonclinical, and impurity analytical method... Read More →

Speakers
JK

Joseph Kauten

Biologics CMC Control Strategy Leader, Shire Pharmaceuticals
Dynamic Technical Leader with a proven track record of value driven innovation, robust process development, and cross-functional influence. Extensive experience in facility and process design from greenfield/brownfield through to successful technology/process transfer, process performance qualification and commercialization of bulk API therapeutics. Established history of developing and leading high performance teams.
avatar for David White

David White

Principal Scientist, AstraZeneca
I joined pharmaceutical development in 2003 as line manager in analytical science working primarily in late phase projects. After secondments to formulated product development and then post approval regulatory, I returned to drug substance in 2014 as a principle scientist responsible for promoting control strategy and measurement science. My current focus is the development of tools to help project teams visualise control strategies earlier... Read More →
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science under Dr. Larry Augsburger at University of Maryland – Baltimore. Wendy is a wife and a mother and shares her love of S.T.E.M. and leadership development through... Read More →


Monday June 27, 2016 10:45am - 12:00pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA