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Repeat Solutions Circle
Browse Sponsored Presentations
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Wed, Oct 8
Thu, Oct 9
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Wednesday, October 8, 2025
10:45 AM - 11:10 AM
EST
Sponsored Presentation: AI for EU MDR-compliant clinical evaluation reports: Tools, tactics, and compliance insights
10:45 AM - 11:10 AM
EST
Sponsored Presentation: AI for EU MDR-compliant clinical evaluation reports: Tools, tactics, and compliance insights
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Shruti Sharma
– Celegence
Sponsor Presentation
Presented By
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Proactivity and best practices in the evolving FDA landscape
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Proactivity and best practices in the evolving FDA landscape
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Sheila R. Plant, PhD, MHS, RAC
– Allucent
Speaker:
Joshua Taylor, PhD, RAC
– Allucent
Speaker:
Matthew Hight, PhD
– Allucent
Speaker:
Bianca N. Quade, PhD
– Allucent
Sponsor Presentation
Presented By
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Transforming regulatory content with AI and ML: Enhancing compliance and patient safety in a Digital Era
10:45 AM - 11:10 AM
EST
Sponsored Presentation: Transforming regulatory content with AI and ML: Enhancing compliance and patient safety in a Digital Era
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Jamie Morisco
– Glemser Technologies
Sponsor Presentation
Presented By
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Agents on the Org Chart: Redefining Quality When AI Operates Within Your QMS
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Agents on the org chart: Redefining quality when AI operates within your QMS
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Erez Kaminski, MS, MBA
– Ketryx Corporation
Sponsor Presentation
Presented by
11:20 AM - 11:45 AM
EST
Sponsored Presentation: From chaos to control: Mapping your RIM maturity journey
11:20 AM - 11:45 AM
EST
Sponsored Presentation: From chaos to control: Mapping your RIM maturity journey
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
James Gianoutsos, MBA
– Rimsys
Speaker:
Shereen Bienz
– Smith+Nephew
Sponsor Presentation
Presented By
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes
11:20 AM - 11:45 AM
EST
Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Brandon Rice, MS
– Weave
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Global supply chain compliance – UDI, EUDAMED, and other emerging use cases
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Global supply chain compliance – UDI, EUDAMED, and other emerging use cases
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Jay Crowley, MS
– USDM Life Sciences
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Regulatory Agility in Action: Avoiding FDA CRLs With the Strategic VDC Approach
11:55 AM - 12:20 PM
EST
Sponsored Presentation: Regulatory agility in action: Avoiding FDA CRLs with the strategic VDC approach
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Michael Day, PhD
– Cencora PharmaLex
Sponsor Presentation
Presented By
11:55 AM - 12:20 PM
EST
Sponsored Presentation: View from the bridge: Navigating the uncertainty with your certification body
11:55 AM - 12:20 PM
EST
Sponsored Presentation: View from the bridge: Navigating the uncertainty with your certification body
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Vishal Thakker, MEng
– BSI
Speaker:
Johnathon William Bis
– BSI
Sponsor Presentation
Presented By
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Case study: How leading global pharma embraces AI to automate regulatory and medical documents of quality control
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Case study: How leading global pharma embraces AI to automate regulatory and medical documents of quality control
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Sharon Chen
– AlphaLife Sciences
Sponsor Presentation
Presented By
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Navigating the ripple effects of FDA downsizing: What it means for life sciences in 2025
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Navigating the ripple effects of FDA downsizing: What it means for life sciences in 2025
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Ritu Dhami
– Network Partners Group (NPG)
Speaker:
Jethro E. Ekuta, DVM, PhD, EMBA, RAC, FRAPS
– Ascendis Pharma, Inc.
Speaker:
Lee W. Evans
– Network Partners Group
Sponsor Presentation
Presented By
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials
12:30 PM - 12:55 PM
EST
Sponsored Presentation: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Tala Fakhouri
– Parexel
Speaker:
Ryan Zettle
– Parexel
Sponsor Presentation
Presented By
3:25 PM - 3:50 PM
EST
Sponsored Presentation: Automating submission dossier with multi-modal AI
3:25 PM - 3:50 PM
EST
Sponsored Presentation: Automating submission dossier with multi-modal AI
Location/Room: Exhibit Hall: Spark! Theater Booth 637
Speaker:
Nick Brown
– Certara
Speaker:
David Meats
– Certara
Sponsor Presentation
Presented By
3:25 PM - 3:50 PM
EST
Sponsored Presentation: The future is now: Transforming regulatory processes through AI, ML, NLP, and RPAs
3:25 PM - 3:50 PM
EST
Sponsored Presentation: The future is now: Transforming regulatory processes through AI, ML, NLP, and RPAs
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Michelle Gyzen
– IQVIA
Sponsor Presentation
Presented By
3:25 PM - 3:50 PM
EST
Sponsored Presentation: The Future of Regulatory Affairs: How Technology Is Shaping Regulatory Compliance
3:25 PM - 3:50 PM
EST
Sponsored Presentation: The future of regulatory affairs: How technology is shaping regulatory compliance
Location/Room: Exhibit Hall: Ignite! Theater Booth 925
Speaker:
Priya Bhutani, BS, MS, MS
– RegDesk, Inc.
Sponsor Presentation
Presented By
4:00 PM - 4:25 PM
EST
Sponsored Presentation: Global regulatory strategy for precision medicine
4:00 PM - 4:25 PM
EST
Sponsored Presentation: Global regulatory strategy for precision medicine
Location/Room: Exhibit Hall: Discover! Theater Booth 425
Speaker:
Kimberley Buytaert-Hoefen, Ph.D
– Pearl Pathways, part of Versiti Clinical Trial Services
Sponsor Presentation
Presented By
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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