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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

Solutions Circles - Booth #200 in Exhibit Hall
Join fellow attendees and industry experts in these small group discussion to exchange ideas and tackle regulatory challenges together.
Know Before You Go & Participation Guidelines:
  • Ticket Pick-up: Get your ticket at the Solutions Circle check-in desk at least 20 minutes before the session. Seating is limited to 30 and available first-come, first-served. Standby tickets are issued once full.
  • Participation: Seats are held only for 3 minutes after the session begins, then released to standby attendees. Please exit promptly at the end; seats cannot be saved between sessions.
  • Full Conference Badge Required: Solutions Circles are open to full-conference registrants only. Please have your badge ready to show. You’ll receive reusable earbuds (yours to keep) for use in all exhibit hall theaters.
Types of Solutions Circles:
  • Continuing the Conversation: Sessions tagged “Solutions Circle: Continuing the Conversation” continue the dialogue from its related breakout session, guided by one of its experts.
  • Repeating Solutions Circles: Many Solutions Circles repeat, giving you the flexibility to attend when it works best for you. Just look for sessions tagged as "Repeat Solutions Circle" (New for 2025!).
  • Sponsor Solutions Circles: Sessions tagged as "Sponsor Solutions Circle" provide an opportunity to engage directly with solution providers in a focused discussion.
*Program and facilitators subject to change. Please check back frequently for updates.

  • Wednesday, Oct 8th
    10:35 AM - 11:05 AM EST
    Solutions Circle (A): Regulatory Consulting-Ins and Outs
    Facilitator: Kamana Singh – APS Pharma Solutions, LLC
    Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
  • 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
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Repeat Solutions CircleBroad Interest & Skill Building
  • Wednesday, Oct 8th
    10:35 AM - 11:05 AM EST
    Solutions Circle (D): Sponsored Solutions Circle: Put Your Model to the Test: Exploring Off-the-Shelf AI for Medical Devices
    Sponsor Facilitator: Jenn Dixon, P.Eng – Ketryx
    Sponsor Solutions Circle
    Facilitated by 
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    Solutions Circle (A): Tips for Successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    Solutions Circle (B): Evolving Health Authority Thinking on Overall Survival for Oncology Trials
    Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Galderma
    Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
  • 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
    Facilitator: Colin S. Jacob, MS – -
    Repeat Solutions CircleBroad Interest & Skill Building
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve
    Facilitator: Anna Spehl, PhD – AKRA TEAM
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (B): Regulatory Affairs: Belonging and Helping Others Belong
    Facilitator: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – NOMSA Regulatory and Writing LLC
    Solutions Circle
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (C): State Licensing for Medical Device Companies: How Does it Apply to Me?
    Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (D): Sponsored Solutions Circle: Making the most of your clinical data matter in your FDA submissions – The dos and don’ts
    Sponsor Facilitator: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
    Sponsor Solutions Circle
    Facilitated By 
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Beat U. Steffen – confinis ag
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    Solutions Circle (D): Sponsored Solutions Circle: Prompt Smarter, Extract Faster: AI Techniques for Scientific Literature
    Sponsor Facilitator: Shruti Sharma – Celegence
    Sponsor Solutions Circle
    Facilitated by 
  • Wednesday, Oct 8th
    3:55 PM - 4:25 PM EST
    Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Solutions Circle (A): Regulatory Consulting-Ins and Outs
    Facilitator: Ann M. Lucchesi, MS – LuCore Regulatory Services LLC
    Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Solutions Circle (B): Quality Culture: How to Make Meaningful Impact as an Early-Career Professional
    Facilitator: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • 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
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Repeat Solutions CircleBroad Interest & Skill Building
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Solutions Circle (D): Sponsored Solutions Circle: What NOT TO DO in RIM Implementations
    Sponsor Facilitator: James Gianoutsos, MBA – Rimsys
    Sponsor Solutions Circle
    Facilitated by 
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    Solutions Circle (A): Tips for successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    Solutions Circle (B): Evolving Health Authority thinking on Overall Survival for Oncology Trials
    Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Galderma
    Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
  • 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
    Facilitator: Colin S. Jacob, MS – -
    Repeat Solutions CircleBroad Interest & Skill Building
  • Thursday, Oct 9th
    11:55 AM - 12:25 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve
    Facilitator: Anna Spehl, PhD – AKRA TEAM
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    11:55 AM - 12:25 PM EST
    Solutions Circle (B): Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials
    Facilitator: Junyang Wang – EMD Serono
    Solutions Circle: Continuing the ConversationPharmaceuticals (includes Biologics & Drugs)
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Beat U. Steffen – confinis ag
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    2:40 PM - 3:10 PM EST
    Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • 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
    Facilitator: Laura DiAngelo, MPH – AgencyIQ POLITICO
    Solutions Circle: Continuing the ConversationBroad Interest & Skill Building