Skip to main content
RAPS Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

  1. Home

  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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 
  • Wednesday, Oct 8th
    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, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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 
  • Thursday, Oct 9th
    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