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Invitation Only

Separate Ticket or Advanced Registration Required

Repeat Solutions Circle

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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