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ExL Pharma 7th Annual Clinical Quality Oversight Forum

Monday, October 17, 2016


Workshop B: Vendor Prequalification: Developing a Standardized and Streamlined Approach to Technical Service Provider Prequalification that Improves Quality and Reduces Risk

Janis Hall, MBA, C.O.P., Senior Consultant, The Avoca Group
Scott A. Harris, Head, Third Parties Quality Management, Sanofi
Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, Associate Director, Quality, Endocyte
Dennis Salotti, M.S., MBA, CCRA, Vice President, Operations, The Avoca Group

  • Assessing the challenges in the prequalification process for technical service providers (TSPs)
    • Outlining current industry dysfunction with regard to TSP prequalification
    • Discussing solutions to current prequalification challenge areas
  • Outlining the design and development of the Avoca Quality Consortium standardized toolset for prequalifying TSPs
    • Walking though the elements of the toolset through interactive case studies
    • Responding to pre-populated mock provider responses to the RFI tool, and working through TSP prequalification process using the tools and data provided
  • Evaluating the implications of centralized and standardized approaches on sponsors, providers and regulatory authorities
  • Identifying opportunities for optimizing quality, efficiency and confidence with better prequalification procedures


Tuesday, October 18, 2016


The Changing Landscape of Clinical Quality and Compliance: Are We at a Tipping Point: Conceptualizing the Future State of Clinical Quality and Compliance and Evaluating the Impact on Today

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, Boston Scientific

Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, Moriah Consultants
Sunil Kotecha, Director, Regulatory Inspection Management, Pfizer
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, Biogen
Ann Meeker-O’Connell, Head, BioResearch Quality and Compliance, Johnson & Johnson
Steve WhittakerExecutive Director, The Avoca Quality Consortium

  • Outlining current compliance needs and wants from sponsors and CROs, and anticipating what their future needs and wants are likely to be
  • Evaluating the impact of global regulatory changes on clinical quality and compliance
    • How do the new ICH E6 mandates impact vendor oversight?
  • Examining the changing landscape of regulatory inspections and the future of inspection management
  • Exploring the developing roles of auditing and quality/ compliance, and how these roles will evolve
  • Addressing compliance at the patient level and the future of informed consent
    • Examining compliance concerns regarding wearables, injestables and other trends
  • Defining data management needs and how they will continue to change
  • Identifying what metrics will and will not be meaningful as the compliance and regulatory landscape evolves
  • Discussing what shifts in variables mean for clinical compliance and quality today



Panel Discussion: Vendor Oversight Within Different Outsourcing Models: Examining the Challenges and Best Practices for Conducting Clinical Quality Oversight of Vendors Under Different Partnership Models

Janis Hall, MBA, C.O.P., Senior Consultant, The Avoca Group

Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB Biosciences, Inc.
Deirdre Hall, M.S., Head, Vendor Quality Management, Clinical Development Quality (CDQ), Pfizer
Samantha A. Vaccaro, MPH, Senior Clinical Trial Manager, Ultragenyx Pharmaceutical Inc.

  • Comparing and contrasting the basics of the strategic partner, preferred provider and functional service provider models
  • Detailing the challenges to oversight within each of these models
    • Outlining specific case studies of issues and how they were overcome
    • Identifying key pieces of advice and guidance to optimize oversight within these models
  • Approaching oversight challenges when working globally within these models
  • Predicting what outsourcing partnerships will look like 20 years from now