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Repeat Solutions Circle

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Wednesday, Oct 8th
10:35 AM - 11:05 AM EST
Solutions Circle (A): Regulatory Consulting-Ins and Outs
Location/Room: Exhibit Hall: Solutions Circle A
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
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 (A): Tips for Successful 10-day Conference Call with FDA
Location/Room: Exhibit Hall: Solutions Circle A
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
Location/Room: Exhibit Hall: Solutions Circle B
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
Location/Room: Exhibit Hall: Solutions Circle C
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
Location/Room: Exhibit Hall: Solutions Circle A
Facilitator: Anna Spehl, PhD – AKRA TEAM
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
Wednesday, Oct 8th
3:20 PM - 3:50 PM EST
Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
Location/Room: Exhibit Hall: Solutions Circle A
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
Location/Room: Exhibit Hall: Solutions Circle C
Facilitator: Beat U. Steffen – confinis ag
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
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
Location/Room: Exhibit Hall: Solutions Circle A
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
Location/Room: Exhibit Hall: Solutions Circle A
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 (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 (A): Tips for successful 10-day Conference Call with FDA
Location/Room: Exhibit Hall: Solutions Circle A
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
Location/Room: Exhibit Hall: Solutions Circle B
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
Location/Room: Exhibit Hall: Solutions Circle C
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
Location/Room: Exhibit Hall: Solutions Circle A
Facilitator: Anna Spehl, PhD – AKRA TEAM
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
Thursday, Oct 9th
2:05 PM - 2:35 PM EST
Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
Location/Room: Exhibit Hall: Solutions Circle A
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
Location/Room: Exhibit Hall: Solutions Circle C
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
Location/Room: Exhibit Hall: Solutions Circle A
Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)