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Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    Preconference Workshop: Claiming Your Seat at the Table: How to Be Included in All Strategic Business Decisions
    Location/Room: 301
    Workshop Leader: Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC
    Workshop Presenter: Susan Speicher, MS, RAC
    Workshop Presenter: Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS)
    Workshop Presenter: Jethro E. Ekuta, DVM, PhD, EMBA, RAC, FRAPS – Ascendis Pharma, Inc.
    Workshop Presenter: Lawrence E. Liberti, MSc, PhD
    Workshop Presenter: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
    Broad Interest & Skill Building
  • Tuesday, Oct 7th
    8:30 AM - 4:00 PM EST
    Preconference Workshop: Strategy and Regulatory Intelligence Primer: Constructing and Maintaining it Using Free and Fee AI Tools
    Location/Room: 403
    Workshop Leader: Meredith Brown-Tuttle, FRAPS – Regulatorium
    Workshop Presenter: Jay H. Mashburn, PhD, RPh – Recursion
    Workshop Presenter: Halee Staggs, MS – LunarLanding.AI LLC
    Workshop Presenter: Joga Gobburu, PhD MBA – University of Maryland
    Workshop Presenter: Howraa Alaskaer
    Broad Interest & Skill Building
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    Government Career Transitions Forum
    Location/Room: 315
    Panel Facilitator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.
    Panelist: Sean Boyd, MPH – QualityHub
    Panelist: Mike Ryan – ELIQUENT Life Sciences
    Panelist: Kimberly A. Trautman, MS – RAPS BoD
    Broad Interest & Skill Building
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    The Power of Mentorship in Regulatory Affairs
    Location/Room: 406
    Presenter: Angelina M. Lisandrelli – Neuros Medical
    Presenter: Lavanya Ramnath, MS – Insulet Corporation
    Presenter: Jasmine G. Muse, MSc – UCB
    Presenter: Numan Shaikh, Masters in Regulatory Affairs – Boston Scientific Corporation
    Broad Interest & Skill Building
  • Wednesday, Oct 8th
    10:35 AM - 11:05 AM EST
    Solutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Repeat Solutions CircleBroad Interest & Skill Building
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    Solutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Colin S. Jacob, MS – -
    Repeat Solutions CircleBroad Interest & Skill Building
  • Wednesday, Oct 8th
    1:00 PM - 2:00 PM EST
    FDA-Regulated Research from the Lens of Institutional Review Boards: Addressing Common Pitfalls and Emerging Trends
    Location/Room: 406
    Presenter: Purna Garimella, MS, CIP, RAC – Indiana University
    Broad Interest & Skill Building
  • Wednesday, Oct 8th
    2:15 PM - 3:15 PM EST
    Empowering Women's Health: Navigating Global Regulatory Challenges and Innovations
    Location/Room: 403
    Presenter: Raquel R. Mura, PharmD, JD, MBA – RGM Life Sciences Consulting
    Presenter: Corinne S. de Vries, MA MSc PhD FISPE – European Medicines Agency
    Presenter: Ritam Priya – Meta
    Presenter: Christy Hillebrecht, RAC – Haleon
    Broad Interest & Skill Building
  • Wednesday, Oct 8th
    4:30 PM - 5:30 PM EST
    The Convergence of Regulatory and Politics: How the President and Congress Will Affect FDA Regulation
    Location/Room: 304
    Presenter: Alexander Gaffney, MS, RAC – AgencyIQ
    Presenter: Laura DiAngelo, MPH – AgencyIQ POLITICO
    Presenter: Remy Brim, PhD – BGR Government Affairs
    Broad Interest & Skill Building
  • Thursday, Oct 9th
    9:15 AM - 10:30 AM EST
    Preparing for the Future: Graduate Education and the Evolving Role of Regulatory Professionals
    Location/Room: 406
    Moderator: Linda F. Bowen, RAC US, RAC EU, RAC CDN, FRAPS – Temple University Pharmacy School
    Presenter: Jonathan Helfgott – Krieger School of Arts & Sciences Johns Hopkins University
    Presenter: Grace Gowda, M. Pharm., PhD, RAC – University of Georgia, College of Pharmacy
    Presenter: Orin Chisholm, GCULT, PhD, SFHEA, FRAPS, FMPP – University of Sydney
    Broad Interest & Skill Building
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Solutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Repeat Solutions CircleBroad Interest & Skill Building
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    Solutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Colin S. Jacob, MS – -
    Repeat Solutions CircleBroad Interest & Skill Building
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    Enhancing Charisma and Influence: Non-Verbal and Digital Body Language for Regulatory Professionals
    Location/Room: 403
    Presenter: Samir A. Shah, PhD – AstraZeneca
    Broad Interest & Skill Building
  • Thursday, Oct 9th
    2:40 PM - 3:10 PM EST
    Solutions Circle (C): The Convergence of Regulatory and Politics: How the President and Congress will Affect FDA Regulation
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Laura DiAngelo, MPH – AgencyIQ POLITICO
    Solutions Circle: Continuing the ConversationBroad Interest & Skill Building
  • Thursday, Oct 9th
    3:15 PM - 4:15 PM EST
    Can GenAI Help Regulatory Teams Scale Up Their Operations? Pitfalls and Best Practices
    Location/Room: 301
    Session Leader: Diogo Geraldes, PhD MEng – Veeva MedTech
    Presenter: Elena Kyria – Elemed
    Presenter: Shereen Bienz – Smith+Nephew
    Presenter: James Dewar – Scarlet
    Broad Interest & Skill Building
  • Thursday, Oct 9th
    4:30 PM - 5:30 PM EST
    Emerging Regulatory Trends, Pre-Marketing Submissions
    Location/Room: 301
    Session Leader: Bassil Akra, PhD – AKRA TEAM
    Presenter: Amra Racic – Veeva MedTech
    Presenter: Tom Melvin, n.a. – Trinity College, Dublin
    Presenter: Richard G. Holborow, n.a. – BSI
    Broad Interest & Skill Building