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Day 1

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Day 1

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10:25am - 10:30am5 mins
Co-Chairs Welcome and Opening Remarks
  • Christopher Biddle - Associate Director, Risk Management and Central Monitoring, Janssen Research
10:30am - 10:50am20 mins
Leadership Perspective: Change Management
    10:55am - 11:15am20 mins
    State of the Industry Report
    • Steve Young - Chief Scientific Officer, CluePoints
    11:15am - 11:20am5 mins
    Take a Break and Visit our Virtual Exhibit Hall!
      11:20am - 12:00pm40 mins
      Panel Debate: State of the Industry from Stakeholders
      • Andy Lawton - Director, Risk-Based Approach Ltd
      • Rosanne Petros, PMP - Associate Director, Clinical Research, Merck Research Laboratories
      • Steve Young - Chief Scientific Officer, CluePoints
      • Esther Huffman O'Keefe - Associate Director, Monitoring, Global Clinical Operations, Regeneron
      • Stephanie Clark - Director, Risk Management - Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson
      12:05pm - 12:25pm20 mins
      Regulatory Review: ICH E8 and ICH E6v3 - How do they Impact RBM and You!
      • Andy Lawton - Director, Risk-Based Approach Ltd
      12:25pm - 1:25pm60 mins
      Grab Some Lunch then Come Back to Join in Networking Activities, Watch Product Showcases, and Connect with Your Key Product and Service Providers in the Virtual Exhibit Hall!
        1:25pm - 1:45pm20 mins
        Regulatory Perspective: Concept of Quality in Clinical Trials
        • Ann Meeker O'Connell - Vice President, Integrated QMS/OMS, Vertex Pharmaceuticals
        1:50pm - 2:10pm20 mins
        Presentation Title TBA - Speaker TBA, Covance
          2:15pm - 2:35pm20 mins
          ICH E6(R3) Review: RBQM Considerations within Annex 2 Applied to Non-Traditional Trials
          • Steve Whittaker - Senior Consultant, The Avoca Group
          2:40pm - 3:40pm60 mins
          Live Speaker Q&A and Roundtable Discussions
          • Christopher Biddle - Associate Director, Risk Management and Central Monitoring, Janssen Research
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