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Day 2 - EST (Eastern Standard Time, GMT-5)

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Day 2 - EST (Eastern Standard Time, GMT-5)

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10:25am - 10:30am5 mins
Welcome to Day 2 from Advisory Board**
    10:30am - 11:00am30 mins
    MHRA Policies and Guidelines on Audit and Inspection Readiness for IRT with Live Q&A
    • Gail Francis - Expert Inspector, GCP, Medicines and Healthcare Products Regulatory Agency (MHRA)
    11:00am - 11:20am20 mins
    IRT Evolution: A Vision for the Future**
    • Jagath Wanninayake - President & CEO, Suvoda
    11:20am - 11:30am10 mins
    Take a Break and Visit our Virtual Exhibit Hall!
      11:30am - 11:50am20 mins
      Ready? Set. Go! Rapid RTSM Implementation for COVID-19 and Beyond**
      • Marc Kaufman - Director - RTSM Customer Adoption and Value Realization, Medidata
      • Mike Radford - Clinical Data Manager, Southampton Clinical Trials Unit, University of Southampton
      • Susannah Condie - Head of Data Management, Southampton Clinical Trials Unit, University of Southampton
      11:50am - 12:20pm30 mins
      Panel: Best Practices and Lessons Learned for Inspection Readiness
      • Simi Nischal - Head of IRT - Clinical Supply Chain, GlaxoSmithKline
      • Prasann Mehta - Director, IRT & COA Services, Merck
      • Carol Lee - Director, Clinical Drug Supply, Logistics and IRT Services, Regeneron
      12:20pm - 1:15pm55 mins
      Grab Some Lunch and Head Back to Connect and Network, Watch Product Showcases, and Connect with Your Key Product and Service Providers in the Virtual Exhibit Hall!
        1:15pm - 1:35pm20 mins
        Amgen Case Study: Innovative Supplied Selection Process
        • Elisa Holzbaur - Manager, Clinical Systems (IRT), Amgen
        1:35pm - 2:10pm35 mins
        Panel Discussion: Design Thinking for IRT
        • Tom Schiavon - Manager, Clinical Systems, Ultragenyx Pharmaceutical Inc.
        • Kim Peplinski - Senior System Design Architect, Team Lead, Project Management, YPrime
        • Bart Nicholson - Director Product Management (IRT), Signant Health
        • Steve McDonald - Director of Business Development, Americas for Almac Clinical Technologies
        2:10pm - 3:10pm60 mins
        Live Speaker Q&A and Networking
        • Simi Nischal - Head of IRT - Clinical Supply Chain, GlaxoSmithKline
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