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Day 1 - EST

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Day 1 - EST

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9:15am - 10:00am45 mins
Let's get moving PT HIIT Session
    10:05am - 10:15am10 mins
    Platform Tutorial
      10:15am - 10:20am5 mins
      Welcome and Opening Remarks
        10:25am - 10:30am5 mins
        Meet our Non-Profit Partner - JerseySTEM
          10:30am - 10:50am20 mins
          Leadership Perspective: Change Management
          • Johann Proeve, Ph.D. - Chief Scientific Officer, Cyntegrity
          • Nico Wegener, Ph.D. - Senior Clinical Project Manager, Merz Pharmaceuticals
          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
              Pivoting RBQM to Mitigate COVID-Borne Risks
              • Kristin Stallcup - Senior Director, Xcellerate Customer Success, 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
              • Lisa Henderson - Group Content Director, Applied Clinical Trials and Pharmaceutical Executive, MJH Associates Inc.
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