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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

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  • Wednesday, Oct 8th
    10:35 AM - 11:05 AM EST
    (repeat) Regulatory Consulting-Ins and Outs
    Facilitator: Kamana Singh – APS Pharma Solutions, LLC
    Pharmaceuticals (includes Biologics & Drugs)Solutions Circle
  • Wednesday, Oct 8th
    10:35 AM - 11:05 AM EST
    (repeat) Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Broad Interest & Skill BuildingSolutions Circle
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    (repeat) Tips for successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    (repeat) Evolving Health Authority Thinking on Overall Survival for Oncology Trials
    Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Karyopharm Therapeutics
    Pharmaceuticals (includes Biologics & Drugs)Solutions Circle
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    (repeat) How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion
    Facilitator: Colin S. Jacob, MS – -
    Solutions Circle
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    (repeat) Submission Gaps in Medical Devices in EU and How to Resolve
    Facilitator: Anna Spehl – AKRA Team
    Solutions Circle
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    State Licensing for Medical Device Companies: How Does it Apply to Me?
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Frederike S. Brühschwein-Mandic – confinis ag
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    (repeat) Submission Gaps in Medical Devices in US and How to Resolve
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Solutions Circle
  • Wednesday, Oct 8th
    3:55 PM - 4:25 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Quality Culture: How to Make Meaningful Impact as an Early-Career Professional
    Facilitator: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    (repeat) Interesting in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering
    Facilitator: Yoshiko Stowell, PhD – Kenai Therapeutics
    Broad Interest & Skill BuildingSolutions Circle
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    (repeat) Regulatory Consulting-Ins and Outs
    Facilitator: Kamana Singh – APS Pharma Solutions, LLC
    Pharmaceuticals (includes Biologics & Drugs)Solutions Circle
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    (repeat) Evolving Health Authority thinking on Overall Survival for Oncology Trials
    Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Karyopharm Therapeutics
    Pharmaceuticals (includes Biologics & Drugs)Solutions Circle
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    (repeat) Tips for successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    (repeat) How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion
    Facilitator: Colin S. Jacob, MS – -
    Solutions Circle
  • Thursday, Oct 9th
    11:55 AM - 12:25 PM EST
    Continuing the Conversation: A Snapshot of Diversity and Inclusion: Where Have We Been and Where Are We Going?
    Facilitator: Junyang Wang – EMD Serono
    Pharmaceuticals (includes Biologics & Drugs)Solutions Circle
  • Thursday, Oct 9th
    11:55 AM - 12:25 PM EST
    (repeat) Submission Gaps in Medical Devices in EU and How to Resolve
    Facilitator: Anna Spehl – AKRA Team
    Solutions Circle
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Frederike S. Brühschwein-Mandic – confinis ag
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    (repeat) Submission Gaps in Medical Devices in US and How to Resolve
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Solutions Circle
  • Thursday, Oct 9th
    2:40 PM - 3:10 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle