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  • Thursday, Mar 5th
    10:30 AM - 11:30 AM East Coast USA Time
    Regulatory Intelligence in Motion: Embedding Strategic Value Across an Evolving Biopharma Enterprise
    Room: Constellation EF
    Presenter: Jeff MacDonald, PharmD (he/him/his) – BeOne Medicines
    Pharmaceuticals & Biologics
  • Thursday, Mar 5th
    11:45 AM - 12:45 PM East Coast USA Time
    Regulatory Considerations and Strategies for the Use of Artificial Intelligence in US Advertising and Promotion
    Room: Constellation EF
    Presenter: Jason Cober – ProPharma
    Presenter: Joanne Hathaway – Genmab (participating in a personal capacity)
    Presenter: Virginia Foley, BA (she/her/hers) – Compliance Forward, LLC
    Pharmaceuticals & Biologics
  • Thursday, Mar 5th
    1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle (3): AI to Securely Cut IND Assembly Time to Quality
    Room: Frederick
    Facilitator: Meelis Lootus, Ph.D – Tehistark
    Pharmaceuticals & Biologics
  • Thursday, Mar 5th
    2:30 PM - 3:30 PM East Coast USA Time
    Gen AI Era: Evolving Landscape of Regulatory Affairs for Cell and Gene Therapy
    Room: Constellation CD
    Presenter: Mridula Shukla, MS – Roche-Genentech
    Pharmaceuticals & Biologics
  • Thursday, Mar 5th
    4:00 PM - 5:00 PM East Coast USA Time
    Reimagining Global Regulatory Strategy for Agility and Impact
    Room: Constellation EF
    Presenter: Tina Kim-Hafken, MSc – Immunome, Inc.
    Presenter: Antonella Lozito, PharmD – Moderna
    Pharmaceuticals & Biologics
  • Friday, Mar 6th
    8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle (3): Global Regulatory Strategy for Orphan Early Stage Drug Development
    Room: Columbia
    Facilitator: Tina Kim-Hafken, MSc – Immunome, Inc.
    Pharmaceuticals & Biologics
  • Friday, Mar 6th
    9:15 AM - 10:15 AM East Coast USA Time
    From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
    Room: Constellation CD
    Presenter: Jonali N. Ramani, RAC – organon
    Pharmaceuticals & Biologics
  • Friday, Mar 6th
    10:45 AM - 11:45 AM East Coast USA Time
    Regulatory Challenges Demystified: Tips, Tools, and Expert Advice
    Room: Constellation EF
    Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
    Pharmaceuticals & Biologics
  • Friday, Mar 6th
    12:00 PM - 1:00 PM East Coast USA Time
    Global Registration Planning Consideration: Integrated Strategy to Solve the Complex Registration Sample Challenge
    Room: Constellation EF
    Presenter: Kingman Ng, PhD – Eli Lilly and Company
    Pharmaceuticals & Biologics