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  • Wednesday, Mar 6th
    11:00 AM – 12:00 PM East Coast USA Time
    The Importance of Precedent in Developing a Regulatory Strategy
    Location: Concourse B
    Pharma/Biologics
  • Wednesday, Mar 6th
    12:15 PM – 1:15 PM East Coast USA Time
    The Importance of and Preparing the Target Product Profile (TPP)
    Location: Concourse B
    Presenter: Mark Levi, PhD – RTI
    Presenter: Xi Yang, PhD, DABT (she/her/hers) – RTI
    Pharma/Biologics
  • Wednesday, Mar 6th
    2:45 PM – 3:45 PM East Coast USA Time
    Global Patient Safety Teams Should Develop the Study's Target Product Profile Safety Section
    Location: Concourse B
    Presenter: Michael E. Kieffer, Pharm.D. – Focused Consulting, Staffing, & Drug Safety, LLC
    Pharma/Biologics
  • Wednesday, Mar 6th
    4:00 PM – 5:00 PM East Coast USA Time
    Global Orphan Drug Regulatory Frameworks
    Location: Concourse B
    Presenter: Jethro E. Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease
    Pharma/Biologics
  • Thursday, Mar 7th
    9:00 AM – 10:00 AM East Coast USA Time
    Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
    Location: Concourse B
    Presenter: Rob Berlin, JD/MPH – GSK
    Presenter: Rasika Kalamegham, PhD – Genentech
    Presenter: Jeff Siegel, MD (he/him/his) – FDA
    Pharma/Biologics
  • Thursday, Mar 7th
    10:30 AM – 11:30 AM East Coast USA Time
    Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
    Location: Concourse B
    Presenter: Rob Berlin, JD/MPH – GSK
    Presenter: Eva Temkin
    Pharma/Biologics
  • Thursday, Mar 7th
    11:45 AM – 12:45 PM East Coast USA Time
    Thinking Beyond Regulatory Approval: The What, Why, When, and How of Pharma Lifecycle Management
    Location: Concourse B
    Pharma/Biologics