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DAY TWO - EST (Eastern Standard Time, GMT-5)

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DAY TWO - EST (Eastern Standard Time, GMT-5)

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8:00am - 8:20am20 mins
HARMONIZATION
Global Harmonization for Clinical Trial Transparency: Progress, opportunities and challenges
  • Julie Holtzople - Head of Clinical Transparency and Data Sharing, AstraZeneca, USA
8:20am - 8:40am20 mins
DATA SHARING REQUIREMENTS
Bioethical Standards – Update on the Good Pharma Score Card other initiatives
  • Jennifer Miller - Founder, Bioethics International and the Good Pharma Scorecard, Assistant Professor, Yale University School of Medicine, USA
8:40am - 9:00am20 mins
DATA SHARING REQUIREMENTS
Considerations for sponsors when using a Data Sharing Platform - Vivli as a case study
  • Julie Wood - Director of Strategy and Operations, Vivli, USA
9:00am - 9:20am20 mins
DATA SHARING REQUIREMENTS
Harmonisation or Re-use of Content from other Clinical Documents of Library of Terms
  • Laura Sheppard - Director of Medical Writing, R&D Operations, Endo, USA
9:20am - 9:40am20 mins
DATA SHARING REQUIREMENTS
Hydrating a Data Lake to Power Innovation - Enabling Pharmaceutical Companies to Automate Data De-Identification for Secondary Use
  • Cathal Gallagher - Senior Life Sciences Consultant, d-wise, USA
  • Kristin McDougall, - Director of Transparency, d-wise, USA
9:40am - 10:20am40 mins
LIVE Virtual Hub Networking
    10:20am - 11:00am40 mins
    DATA SHARING REQUIREMENTS
    PANEL: Harmonization- Requirements of what we Have to do? What does the Future look like Post-Brexit?
    • Amanda Hunn - Principal, l, A J Hunn Associates
    • Alexander Roussanov - International Partner, Arnold & Porter, Belgium
    11:00am - 11:20am20 mins
    LEARNINGS FROM THE FUTURE OF COVID-19
    Downstream Benefits of Transparency
    • Thomas Wicks - Chief Strategy Officer, TrialScope
    11:20am - 11:40am20 mins
    LEARNINGS FROM THE FUTURE OF COVID-19
    SPOTLIGHT PRESENTATION
      11:40am - 12:00pm20 mins
      LEARNINGS FROM THE FUTURE OF COVID-19
      SPOTLIGHT PRESENTATION
        12:00pm - 12:40pm40 mins
        LIVE Virtual Hub Networking
          12:40pm - 1:00pm20 mins
          LEARNINGS FROM THE FUTURE OF COVID-19
          Plain Language Summaries of Publications: A New Approach to Providing Easy to Understand Information about COVID-19 Vaccine Trials
          • Sarah Griffiths - Communications Team Leader, Patient Engagement, Oxford PharmaGenesis Ltd, UK
          • Kimbra Edwards - Senior Manager, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP), USA
          1:00pm - 1:20pm20 mins
          LEARNINGS FROM THE FUTURE OF COVID-19
          CASE STUDY: Lessons Learned from COVID-19 Vaccine Disclosure Requirements
          • Lora Killian - Transparency and Disclosure Lead, Pfizer, USA
          1:20pm - 2:00pm40 mins
          LEARNINGS FROM THE FUTURE OF COVID-19
          PANEL: The Changing Transparency Environment in the Covid age
          • Thomas Wicks - Chief Strategy Officer, TrialScope
          • Nicholas DeVito - DPhil Candidate and Researcher, University of Oxford, UK
          • Scott Patton - Clinical Trials Manager, Stanford Medicine Research Office, USA
          • Behtash Bahador - Associate Director, Relationship Management and Development, Center for Information & Study on Clinical Research Participation (CISCRP), USA
          2:00pm - 2:05pm5 mins
          End of Day One
            DAY ONE
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