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Risk-based monitoring and other risk-based approaches to ensure clinical quality are focal points of the upcoming 3rd Quality Oversight of Clinical Vendors Conference, taking place
October 22-24 at the Westin in Alexandria, VA.
Join us at this highly interactive forum to discuss with industry experts their experiences, best practices, lessons learned and future plans for developing risk based approaches for assessing and managing clinical quality.
Featured Sessions on Risk-Based Strategies:
PANEL DISCUSSION - FDA'S RISK-BASED MONITORING GUIDANCE
How are Sponsors and CROs Implementing the
Guidance and what is the Impact on Assessing the Quality of Monitoring?
Moderator:
Maryann Livolsi, MSN, RN, Director, R&D Compliance & Process, SHIRE
Panelists:
Linda Brown, Director QA, KOWA RESEARCH INSTITUTE, INC.
Neil McCullough, PhD, MSc, CChem, MRSC,
MRQA, CISA, Vice President, Global Quality & Compliance, PPD
Nancy J.
Perrella, JD, Director, Regulatory Policy & Compliance, COVANCE
Jennifer J.
Poulakos, PhD, Director, Clinical Quality Assurance, AGENSYS, INC.
QUALITY BY DESIGN
Applying a Quality by Design Approach to Clinical Vendor
Oversight to Minimize Risks
Tom Burke, RN, BSN, CCRP, GCP Compliance Senior Manager, ENDO PHARMACEUTICALS
David Nickerson, Senior Director, Clinical Quality Management, PFIZER
CASE STUDY - A GLOBAL RISK-BASED CO-MONITORING APPROACH TO OVERSIGHT
Design and Execution of an Oversight Program that Focuses on CRA Training and
Frequent Co-Monitoring Visits to Ensure Compliance with Extremely Complex Protocols
Sarah Jane Constantine, Senior Manager, Clinical Trial GCP Compliance, CUBIST
CREATING A VENDOR RISK PROFILE
Establishing a Criteria for Effectively Assessing the Risk of Potential Vendors
Angela Berns, Associate Director and Head of Vendor Program,
Clinical Quality Assurance, UCB BIOSCIENCES INC.
HALF-DAY WORKSHOP - A RISK-BASED APPROACH TO OVERSIGHT
Developing a Systematic, Prioritized and Risk-Based
Approach to Quality Oversight Monitoring of Vendor Deliverables
Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS; Member, Board of Trustees, ASSOCIATION OF CLINICAL RESEARCH
PROFESSIONALS (ACRP)
Jennifer J.
Poulakos, PhD, Director, Clinical Quality Assurance, AGENSYS, INC.
Click here for a detailed agenda.
Please Use
Priority Code: C222ACT |
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