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Repeat Solutions Circle
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Wed, Oct 8
Thu, Oct 9
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Thursday, October 9, 2025
10:45 AM - 11:10 AM
EST
Sponsored Presentation: A regulatory affairs year to remember: Leveraging learnings to move forward in 2026
10:45 AM - 11:10 AM
EST
Sponsored Presentation: A regulatory affairs year to remember: Leveraging learnings to move forward in 2026
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Jim DiBiasi
– 3D Communications - ENTERPRISE
Speaker:
Virginia Cox, JD
– 3D Communications
Speaker:
Jeanne Ireland, MA
– Ireland Strategies, LLC
Speaker:
Elaine Lippmann, JD
– Leavitt Partners
Speaker:
Sue Sutter
– Pink Sheet
Sponsor Presentation
Presented By
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Ensuring compliance across the distribution chain: A deep dive into economic operators’ roles
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Ensuring compliance across the distribution chain: A deep dive into economic operators’ roles
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Daryl Wisdahl
– MedEnvoy Global
Sponsor Presentation
Presented By
10:45 AM - 11:10 AM
EST
Sponsored Presentation: No hype, just help: AI tools that support your daily regulatory workflow
10:45 AM - 11:10 AM
EST
Sponsored Presentation: No hype, just help: AI tools that support your daily regulatory workflow
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Michelle Wu
– NyquistAI
Sponsor Presentation
Presented By
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Global regulatory strategy: Change management
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Global regulatory strategy: Change management
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Evangeline Loh, PhD, RAC (US, EU)
– Emergo by UL
Speaker:
Ken Pilgrim
– Emergo by UL
Sponsor Presentation
Presented By
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Revisiting EU MDR: Stakeholder Voices, Regulatory Shifts, and Notified Body Improvements
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Revisiting EU MDR: Stakeholder Voices, Regulatory Shifts, and Notified Body Improvements
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Curtis Riley, MStJ MBA MIET MTOPRA
– Intertek Medical Notified Body AB
Sponsor Presentation
Presented By
11:20 AM - 11:45 AM
EST
Sponsored Presentation: RI impact: How AI and systematic reviews deliver measurable and actionable regulatory intelligence
11:20 AM - 11:45 AM
EST
Sponsored Presentation: RI impact: How AI and systematic reviews deliver measurable and actionable regulatory intelligence
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Ivan Perez Chamorro
– MedBoard
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Convergence and reliance at a crossroads: Accelerating submissions and addressing priorities in post approval changes
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Convergence and reliance at a crossroads: Accelerating submissions and addressing priorities in post approval changes
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Vladimir P. Penkrat, MBA
– Indegene, Inc.
Speaker:
Rachana Dubey
– Indegene Inc.
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Implementing flexibility and efficiency in labeling change management
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Implementing flexibility and efficiency in labeling change management
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Anthony Pulleo
– Bayer
Speaker:
Colleen Witt, MS, RAC
– Bayer
Speaker:
Kate Mains, RAC
– Bayer
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: MIT’s AI Report: Why Most AI Implementations Fail—Lessons from AI Case Studies in Regulatory Affairs
11:55 AM - 12:20 PM
EST
Sponsored Presentation: The MIT AI Report: Why Most AI Implementations Fail—Lessons from AI Case Studies in Regulatory Affairs
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Soumya Mahapatra
– Essenvia
Speaker:
Sejal Chitre
– Terumo Medical Corp.
Speaker:
Brian Byrd
– Terumo Medical Corp.
Sponsor Presentation
Presented by
2:10 PM - 2:35 PM
EST
Sponsored Presentation: Clinical evaluation reports: Notified Body expectations
2:10 PM - 2:35 PM
EST
Sponsored Presentation: Clinical evaluation reports: Notified Body expectations
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Kevin Holochwost
– SGS North America
Sponsor Presentation
Presented by
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