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  • Wednesday, Oct 4th
    8:00 AM – 9:15 AM EDT
    Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs
    Location/Room: 513F
    Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
    Presenter: Brittany Caldwell
    Presenter: Ritu Dhami – Network Partners Group
    Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia
    Presenter: Elena Kyria – Elemed
    Presenter: Brian Savoie – RAPS
    Skill Building
  • Wednesday, Oct 4th
    2:00 PM – 3:00 PM EDT
    Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them
    Location/Room: 513F
    Session Leader: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
    Moderator: Amra Racic – Veeva Systems
    Skill Building
  • Wednesday, Oct 4th
    3:30 PM – 4:30 PM EDT
    The Future of Regulatory Affairs In An Everchanging World
    Location/Room: 513F
    Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Presenter: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
    Skill Building
  • Wednesday, Oct 4th
    4:45 PM – 5:45 PM EDT
    Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies
    Location/Room: 513F
    Moderator: Adriana Racolta, PhD, RAC – Seagen, Inc
    Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
    Presenter: Christine Mayer-Nicolai, PhD – Merck KGaA, Darmstadt, Germany
    Presenter: Mike Wierzba, PhD – GSK
    Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
  • Thursday, Oct 5th
    8:00 AM – 9:15 AM EDT
    Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.
    Location/Room: 513F
    Presenter: Derecka Alexander, MPH, DVM – American Association for the Advancement of Science/USDA
    Presenter: Marcus S. Delatte, PhD – Allucent
    Presenter: Owen McMaster, PhD – Food and Drug Administration
    Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
  • Thursday, Oct 5th
    2:00 PM – 3:00 PM EDT
    Importance of Building Relationships with Health Authorities: Case Study for NDA Review of Orphan Product
    Location/Room: 510B
    Presenter: AJ Acker – Annexon Biosciences
    Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences
    Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration
    Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
    Skill Building
  • Thursday, Oct 5th
    3:30 PM – 4:30 PM EDT
    The Art of Submission Planning: From Strategy to Filing
    Location/Room: 513F
    Skill Building
  • Thursday, Oct 5th
    4:45 PM – 5:45 PM EDT
    Financial Acumen for Regulatory Affairs
    Location/Room: 513F
    Session Leader: Megha Iyer, MS, RAC – Thermo Fisher Scientific
    Presenter: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
    Presenter: Susan Speicher, MS – UpToDate, Inc.
    Skill Building