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Wednesday, June 29 • 2:00pm - 3:15pm
#346: Anticipating and Responding to Challenges in Issue Management

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Limited Capacity seats available

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.


Susan V. Callery-D'Amico, BSN


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

FDA Perspective
Jean M. Mulinde, MD

avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →

avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Kenneth Wu

Kenneth Wu

Consultant, Kenneth Wu and Associates
Kenneth Wu is the principal consultant at Kenneth Wu and Associates, LLC. He has been consulting for the past ten years. His clients have spanned from large global pharmaceutical companies, biotechnology start ups, medical device companies to contract research organizations (CROs... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Session