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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

Full Schedule

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  2. Full Schedule
*Program and presenters subject to change. Please check back frequently for updates.

Full Schedule

  • Wednesday, October 8, 2025
  • 6:30 AM - 5:00 PM EST
    Speaker Ready Room
  • 6:30 AM - 5:30 PM EST
    Convergence App Support Hours
  • 6:30 AM - 5:30 PM EST
    Registration Hours
  • 6:30 AM - 5:30 PM EST
    Wellness Room
  • 7:00 AM - 8:00 AM EST
    Community Gathering & Morning Coffee
  • 7:00 AM - 6:00 PM EST
    First Aid Office Hours
  • 7:00 AM - 6:00 PM EST
    RAPS Store Hours
  • 8:00 AM - 9:00 AM EST
    Plenary Session: Bridging the Access Gaps: Regulatory Pathways to Equitable Innovation
  • 9:15 AM - 10:30 AM EST
    A Snapshot of Diversity and Inclusion: Where Have We Been and Where Are We Going?
  • 9:15 AM - 10:30 AM EST
    Advertisement & Promotional Material
  • 9:15 AM - 10:30 AM EST
    Embracing the Age of Generative AI in Drug Development
  • 9:15 AM - 10:30 AM EST
    EU MDR Kick-Off: “The Latest and Greatest News from Europe”
  • 9:15 AM - 10:30 AM EST
    Expedited Programs to Support the Development and Approval of Products for Unmet Medical Needs
  • 9:15 AM - 10:30 AM EST
    Government Career Transitions Forum
  • 9:15 AM - 10:30 AM EST
    Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network
  • 9:15 AM - 10:30 AM EST
    The Power of Mentorship in Regulatory Affairs
  • 10:30 AM - 11:00 AM EST
    Refreshment Break in the Exhibit Hall
  • 10:30 AM - 11:15 AM EST
    RAPS Chapter/LNG Meet & Greets in Career Central
  • 10:30 AM - 1:00 PM EST
    Exclusive Exhibit Hall Hours: Networking & Presentations
  • 10:30 AM - 1:00 PM EST
    Pawsitive Reinforcement
  • 10:30 AM - 4:30 PM EST
    Exhibit Hall Open Hours
  • 10:30 AM - 4:30 PM EST
    RAPS Sales Lounge Hours
  • 10:35 AM - 11:05 AM EST
    (repeat) Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering
  • 10:35 AM - 11:05 AM EST
    (repeat) Regulatory Consulting-Ins and Outs
  • 10:35 AM - 11:05 AM EST
    Solutions Circle (D): Sponsored Solutions Circle: Put Your Model to the Test: Exploring Off-the-Shelf AI for Medical Devices
  • 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: Proactivity and best practices in the evolving FDA landscape
  • 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 - 11:45 AM EST
    Career Central Stage: RAPS Credentials: Create an Actionable Roadmap for you and your team
  • 11:00 AM - 11:30 AM EST
    RAPS Central Board Round Up: How to Become a RAPS Fellow
  • 11:15 AM - 11:45 AM EST
    (repeat) Evolving Health Authority Thinking on Overall Survival for Oncology Trials
  • 11:15 AM - 11:45 AM EST
    (repeat) How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion
  • 11:15 AM - 11:45 AM EST
    (repeat) Tips for successful 10-day Conference Call with FDA
  • 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: From chaos to control: Mapping your RIM maturity journey
  • 11:20 AM - 11:45 AM EST
    Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes
  • 11:30 AM - 12:30 PM EST
    Speed Mentoring in Career Central, Exhibit Hall (Sign-Up Required)
  • 11:30 AM - 1:00 PM EST
    Networking Lunch in the Exhibit Hall
  • 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: Regulatory Agility in Action: Avoiding FDA CRLs With the Strategic VDC Approach
  • 11:55 AM - 12:20 PM EST
    Sponsored Presentation: View from the bridge: Navigating the uncertainty with your certification body
  • 11:55 AM - 12:25 PM EST
    (repeat) Submission Gaps in Medical Devices in EU and How to Resolve
  • 11:55 AM - 12:25 PM EST
    Regulatory Affairs: Belonging and Helping Others Belong
  • 11:55 AM - 12:25 PM EST
    Solutions Circle (D): Sponsored Solutions Circle: Making the most of your clinical data matter in your FDA submissions – The dos and don’ts
  • 11:55 AM - 12:25 PM EST
    State Licensing for Medical Device Companies: How Does it Apply to Me?
  • 12:00 PM - 12:30 PM EST
    RAPS Central Board Round Up: Practical, Ethical Use of AI in Regulatory
  • 12:00 PM - 12:45 PM EST
    Career Central Stage: From Potential to Performance: How Regulatory Functions are Adopting AI
  • 12:00 PM - 1:00 PM EST
    RAPS Certification Lounge: Ask RAC & RCC Holders: Get your Certification Questions Answered
  • 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: Navigating the ripple effects of FDA downsizing: What it means for life sciences in 2025
  • 12:30 PM - 12:55 PM EST
    Sponsored Presentation: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials
  • 1:00 PM - 2:00 PM EST
    A Lean System to Report Supply Interruptions and Discontinuations (Article 10a in EU, RoW)
  • 1:00 PM - 2:00 PM EST
    Challenges in Precision Medicine Product Development
  • 1:00 PM - 2:00 PM EST
    FDA-Regulated Research from the Lens of Institutional Review Boards: Addressing Common Pitfalls and Emerging Trends
  • 1:00 PM - 2:00 PM EST
    ICH Q1: 20 Years of Stability and a 2025 Transformation
  • 1:00 PM - 2:00 PM EST
    Modeling the Future: Regulatory Perspectives on In Silico Tools for Medical Devices
  • 1:00 PM - 2:00 PM EST
    Navigating the New Frontier: The Impact of Joint Clinical Assessments on Regulatory Affairs
  • 1:00 PM - 2:00 PM EST
    Translating the AI Regulatory Landscape to Quality Management Systems: EU MDR, ISO/IEC 42001, and Beyond
  • 2:15 PM - 3:15 PM EST
    Accelerating Cell Therapy Development: Challenges and Opportunities
  • 2:15 PM - 3:15 PM EST
    Accelerating China Market Access for Medical Devices: Regulatory Shifts, Clinical Leverage & Strategic Insights
  • 2:15 PM - 3:15 PM EST
    Data Science and Management: Strength of Collaborations for Evidence Generation to Advance Medical Product Development
  • 2:15 PM - 3:15 PM EST
    Decoding and Understanding Artificial Intelligence (AI)
  • 2:15 PM - 3:15 PM EST
    Empowering Women's Health: Navigating Global Regulatory Challenges and Innovations
  • 2:15 PM - 3:15 PM EST
    FDA Forecast: What the FDA has Planned in 2026 for Pharmaceuticals and Biotechnology Products
  • 2:15 PM - 3:15 PM EST
    International Regulators Forum
  • 2:15 PM - 3:15 PM EST
    Latest Developments in PFAS
  • 3:15 PM - 3:45 PM EST
    Refreshment Break in the Exhibit Hall
  • 3:15 PM - 4:15 PM EST
    Career Central Stage: Live LinkedIn Feedback Session
  • 3:15 PM - 4:30 PM EST
    Exclusive Exhibit Hall Hours: Networking & Presentations
  • 3:15 PM - 4:30 PM EST
    Pawsitive Reinforcement
  • 3:15 PM - 4:30 PM EST
    RAPS Certification Lounge: Exclusive Lounge Hours for RAC & RCC Holders
  • 3:20 PM - 3:50 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
  • 3:20 PM - 3:50 PM EST
    (repeat) Submission Gaps in Medical Devices in US and How to Resolve
  • 3:20 PM - 3:50 PM EST
    Solutions Circle (D): Sponsored Solutions Circle: Prompt Smarter, Extract Faster: AI Techniques for Scientific Literature
  • 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: The future is now: Transforming regulatory processes through AI, ML, NLP, and RPAs
  • 3:25 PM - 3:50 PM EST
    Sponsored Presentation: The Future of Regulatory Affairs: How Technology Is Shaping Regulatory Compliance
  • 3:45 PM - 4:15 PM EST
    RAPS Central Board Round Up: Regulatory Leadership
  • 3:55 PM - 4:25 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
  • 4:00 PM - 4:25 PM EST
    Sponsored Presentation: Global regulatory strategy for precision medicine
  • 4:30 PM - 5:30 PM EST
    AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness
  • 4:30 PM - 5:30 PM EST
    Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs
  • 4:30 PM - 5:30 PM EST
    Enhancing the Collection, Communication, and Use of Patient Experience Data: Current Status and Next Steps
  • 4:30 PM - 5:30 PM EST
    International Reliance and Work-Sharing Programs: Speeding up Access to Medicines
  • 4:30 PM - 5:30 PM EST
    Navigating the Future of mRNA Therapeutics-Exploration of Draft Guidelines, Industry Challenges, and Expert Insights
  • 4:30 PM - 5:30 PM EST
    Rethinking Regulatory Strategy: De-risking Submissions and Addressing Payer Needs with Comprehensive Evidence Planning
  • 4:30 PM - 5:30 PM EST
    Sustainability, Green, EcoDesign
  • 4:30 PM - 5:30 PM EST
    The Convergence of Regulatory and Politics: How the President and Congress Will Affect FDA Regulation
  • 5:45 PM - 7:15 PM EST
    Honoring Excellence: RAPS 2025 Awards Celebration (Invitation Only)
  • 6:00 PM - 9:00 PM EST
    Dine Arounds (Advanced Sign-up Required)
  • 7:30 PM - 10:00 PM EST
    SOLD OUT: Convergence Networking Party at Acrisure Stadium (Separate Ticketed Event)