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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.
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Wednesday, Oct 8th
10:35 AM - 11:05 AM ESTSolutions Circle (A): Regulatory Consulting-Ins and OutsFacilitator: – APS Pharma Solutions, LLC
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
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Wednesday, Oct 8th
10:35 AM - 11:05 AM ESTSolutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of VolunteeringFacilitator: – Kenai Therapeutics
Repeat Solutions CircleBroad Interest & Skill Building
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Wednesday, Oct 8th
10:35 AM - 11:05 AM ESTSolutions Circle (D): Sponsored Solutions Circle: Put Your Model to the Test: Exploring Off-the-Shelf AI for Medical DevicesSponsor Facilitator: – Ketryx
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Wednesday, Oct 8th
11:15 AM - 11:45 AM ESTSolutions Circle (A): Tips for Successful 10-day Conference Call with FDAFacilitator: – BD - Becton, Dickinson and Company
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Wednesday, Oct 8th
11:15 AM - 11:45 AM ESTSolutions Circle (B): Evolving Health Authority Thinking on Overall Survival for Oncology TrialsRepeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
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Wednesday, Oct 8th
11:15 AM - 11:45 AM ESTSolutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits DiscussionRepeat Solutions CircleBroad Interest & Skill Building
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Wednesday, Oct 8th
11:55 AM - 12:25 PM ESTSolutions Circle (A): Submission Gaps in Medical Devices in EU and How to ResolveRepeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Wednesday, Oct 8th
11:55 AM - 12:25 PM ESTSolutions Circle (B): Regulatory Affairs: Belonging and Helping Others BelongFacilitator: – NOMSA Regulatory and Writing LLC
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Wednesday, Oct 8th
11:55 AM - 12:25 PM ESTSolutions Circle (C): State Licensing for Medical Device Companies: How Does it Apply to Me?Facilitator: – QARA Solutions, LLC
Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Wednesday, Oct 8th
11:55 AM - 12:25 PM ESTSolutions Circle (D): Sponsored Solutions Circle: Making the most of your clinical data matter in your FDA submissions – The dos and don’tsSponsor Facilitator: – NDA Partners
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Wednesday, Oct 8th
3:20 PM - 3:50 PM ESTSolutions Circle (A): Submission Gaps in Medical Devices in US and How to ResolveRepeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Wednesday, Oct 8th
3:20 PM - 3:50 PM ESTSolutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to IndustryFacilitator: – confinis ag
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Wednesday, Oct 8th
3:20 PM - 3:50 PM ESTSolutions Circle (D): Sponsored Solutions Circle: Prompt Smarter, Extract Faster: AI Techniques for Scientific LiteratureSponsor Facilitator: – Celegence
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Wednesday, Oct 8th
3:55 PM - 4:25 PM ESTSolutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management StrategiesFacilitator: – Bridging Consulting LLC
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
10:35 AM - 11:05 AM ESTSolutions Circle (A): Regulatory Consulting-Ins and OutsFacilitator: – LuCore Regulatory Services LLC
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
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Thursday, Oct 9th
10:35 AM - 11:05 AM ESTSolutions Circle (B): Quality Culture: How to Make Meaningful Impact as an Early-Career ProfessionalFacilitator: – Analog Devices
Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
10:35 AM - 11:05 AM ESTSolutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of VolunteeringFacilitator: – Kenai Therapeutics
Repeat Solutions CircleBroad Interest & Skill Building
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Thursday, Oct 9th
10:35 AM - 11:05 AM ESTSolutions Circle (D): Sponsored Solutions Circle: What NOT TO DO in RIM ImplementationsSponsor Facilitator: – Rimsys
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Thursday, Oct 9th
11:15 AM - 11:45 AM ESTSolutions Circle (A): Tips for successful 10-day Conference Call with FDAFacilitator: – BD - Becton, Dickinson and Company
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
11:15 AM - 11:45 AM ESTSolutions Circle (B): Evolving Health Authority thinking on Overall Survival for Oncology TrialsRepeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
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Thursday, Oct 9th
11:15 AM - 11:45 AM ESTSolutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits DiscussionRepeat Solutions CircleBroad Interest & Skill Building
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Thursday, Oct 9th
11:55 AM - 12:25 PM ESTSolutions Circle (A): Submission Gaps in Medical Devices in EU and How to ResolveRepeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
11:55 AM - 12:25 PM ESTSolutions Circle (B): Enhancing Understanding of Biologic Variability Through Representation in Clinical TrialsFacilitator: – EMD Serono
Solutions Circle: Continuing the ConversationPharmaceuticals (includes Biologics & Drugs)
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Thursday, Oct 9th
2:05 PM - 2:35 PM ESTSolutions Circle (A): Submission Gaps in Medical Devices in US and How to ResolveRepeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
2:05 PM - 2:35 PM ESTSolutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to IndustryFacilitator: – confinis ag
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
2:40 PM - 3:10 PM ESTSolutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management StrategiesFacilitator: – Bridging Consulting LLC
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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Thursday, Oct 9th
2:40 PM - 3:10 PM ESTSolutions Circle (C): The Convergence of Regulatory and Politics: How the President and Congress will Affect FDA RegulationFacilitator: – AgencyIQ POLITICO
Solutions Circle: Continuing the ConversationBroad Interest & Skill Building