DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Quality oversight throughout the clinical development life cycle is complex, crosses many functions, and can pose changes in seamlessly communicating and managing quality risks identified along the way. This session will discuss the role of executive leadership in driving and ensuring transparent communication about quality throughout an organization. Additionally, presenters will describe how their organizations have developed and implemented a enterprise quality management approach tailored to their particular context.

Learning Objectives

Identify the benefits of implementing a holistic, clinical-focused quality management system; Discuss how enterprise quality management can be tailored to an organization’s operating context; Recognize how executive leadership can drive a quality-focused culture and timely execution.

Chair

Ann Meeker-O'Connell, MS

Speaker

Executive Leadership Position on Quality
John Hubbard, PhD

Establishing a Quality Management System During Accelerated Growth of a Lean Operation
Coleen Glessner, MBA

Research and Development QA Integrated Quality Strategy: An Approach to Ensuring Quality and Managing Quality Risks Across the Drug Life Cycle
Kevin Grebner

Component Type: Session
Level: Intermediate
CE: CME 0.50; IACET 0.50; RN 0.50

Design thinking is a customer-centric approach designers use to solve complex problems. A design mindset is focused on solutions, starting with the perspective of the end-user-and their needs. This session will provide a brief introduction to design thinking, describe its benefits and potential applications to clinical development, and provide a brief example of how one company applied the methodology. The session will be followed by an Engage and Exchange session where participants will apply design thinking concepts hands on.

Learning Objectives

Recognize the basics of design thinking; Describe the case for applying the design thinking methodology in clinical development; Identify areas in which design thinking could be applied in clinical development to enhance trial success and the participant experience.

Chair

Patricia Leuchten

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Knowledge is a valuable asset that organizations acquire through experience and possess within their employees. Implementing a structured approach to managing knowledge can effectively help achieve desired business outcomes of quality improvements and employee engagement. This session will provide an overview of key principles of knowledge management (KM), discuss elements of a KM framework that can support application within clinical development, and offer ideas on how KM practices can be applied to specific business processes.

Learning Objectives

Recognize key principles of knowledge management and suggested approaches to implementation strategy; Identify a knowledge management framework that can be tailored and applied within a clinical development organization; Discuss how knowledge management may be applied to a specific business process or functions.

Chair

Kathy Salzano

Speaker

Overview of TransCelerate Conceptual Knowledge Management Framework
Christa A. Maurer

Unlocking the Mystery of Knowledge Management: Applying Concepts to a Trial Master File
David William Fryrear, MSc

Application of Knowledge Management in Regulatory Intelligence
Carolyn Louise Hynes, PhD

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will include an overview of the Transcelerate Issue Management Conceptual Framework and theTrancelerate Trending and Analytics. We will discuss innovative solutions for managing, monitoring, and mitigating protocol deviations and include a CRO perspective on managing issues and explains how a triage mechanism sorts the plethora of issues to allow focus on issues that matter in the clinical development space, and use of methodologies should bring about a decrease in issues.

Learning Objectives

Describe key aspects of effective, sustainable issue management from triage to effectiveness actions; Identify the benefits of a conceptual approach for proactive planning and implementation of trending issues and the use of predictive analytic activities in risk mitigation and proactive risk management; Discuss the negative impact from protocol deviations and how to proactively and continuously manage this risk; Identify innovative solutions to manage, monitor and mitigate protocol deviations.

Chair

Susan V. Callery-D'Amico, BSN

Speaker

Controlling the Killer KRI: New Solutions to Address Protocol Deviations
Kenneth Wu

FDA Perspective
Jean M. Mulinde, MD

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Quality must be assured at all stages of clinical development. Quality planning and risk management begins well before the first protocol for a clinical program is drafted and continues through the life cycle of the product, including postmarking studies. Approaches, including protocols assessment by cross-functional teams and development of control strategies, can identify and address risks before the study starts. At the other end of the clinical development cycle, interest in postmarketing, noninterventional studies is increasing from both the regulatory perspective and their potential support new indications. This session will discuss how these studies have their own set of challenges, yet proper oversight can be achieved through innovative approaches.

Learning Objectives

Describe a framework to reduce risk in early-phase trials; Identify how to drive value from the protocol review stage; Discuss the necessity and challenges of cross-functional risk assessment; Describe the current landscape and expectations for sponsors of non-interventional research; Recognize oversight activities with respect to challenges of postmarketing observational trials; Discuss innovative solutions for overcoming the challenges through risk adapted surveillance activities.

Chair

David William Fryrear, MSc

Speaker

A Proactive QRM Framework that Breaks Down Functional Silos and Drives Higher Quality into Clinical Trials
Tim Strauss, MS

Sponsor Oversight of Non-Interventional Research
Christine R. Sahagian, MS

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will describe some of the unique challenges with conducting clinical trials in China. We will describe approaches and challenges with the application of good clinical practices and include information on how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Learning Objectives

Describe approaches and challenges with application of GCPs in China; Identify how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Chair

Daniel Liu, PhD, MSc

Speaker

Overview of Steps to Doing a Clinical Trial in China
Daniel Liu, PhD, MSc

Risk-Based Monitoring and Enrollment Pattern Analysis: Efficient Approaches for the Assessment Required by CFDA
Wenjun Bao, PhD

Update on Clinical Trials in China
Carol Zhu, MBA