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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

  • Thursday, October 9, 2025
  • 6:30 AM - 4:30 PM EST
    Speaker Ready Room
  • 6:30 AM - 5:30 PM EST
    Wellness Room
  • 7:00 AM - 8:00 AM EST
    Community Gathering & Morning Coffee
  • 7:00 AM - 3:00 PM EST
    Registration Hours
  • 7:00 AM - 5:00 PM EST
    RAPS Store Hours
  • 7:00 AM - 6:00 PM EST
    Bag & Coat Check
  • 7:00 AM - 6:00 PM EST
    First Aid Office Hours
  • 7:30 AM - 3:00 PM EST
    Convergence App Support Hours
  • 8:00 AM - 9:00 AM EST
    Plenary Session In Their Words A Patients Journey Through Treatment and Trust
  • 8:15 AM - 10:30 AM EST
    Building Resilient Drug Supply Chains: Advanced Strategies for Critical Shortage Prevention
  • 9:15 AM - 10:30 AM EST
    CANCELLED: Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research
  • 9:15 AM - 10:30 AM EST
    Combination Products & Companion Diagnostics
  • 9:15 AM - 10:30 AM EST
    EU Notified Body Forum: Tips and Tricks for Effective MDR/IVDR Implementation
  • 9:15 AM - 10:30 AM EST
    Navigating the New US Regulatory Landscape for the MedTech Industry: Trends and Changes, Including MDUFA
  • 9:15 AM - 10:30 AM EST
    Orphan Devices
  • 9:15 AM - 10:30 AM EST
    Preparing for the Future: Graduate Education and the Evolving Role of Regulatory Professionals
  • 9:15 AM - 10:30 AM EST
    Regulatory & Global Health
  • 10:30 AM - 11:00 AM EST
    Refreshment Break in the Exhibit Hall
  • 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 - 3:30 PM EST
    Exhibit Hall Open Hours
  • 10:30 AM - 3:30 PM EST
    RAPS Sales Lounge Hours
  • 10:35 AM - 11:05 AM EST
    (repeat) Interesting 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
    Quality Culture: How to Make Meaningful Impact as an Early-Career Professional
  • 10:35 AM - 11:05 AM EST
    Solutions Circle (D): Sponsored Solutions Circle: What NOT TO DO in RIM Implementations
  • 10:45 AM - 11:00 AM EST
    Student Capstone Presentation: Enhancing Informed Consent: A Study on Novel Barriers to Implementation
  • 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: Ensuring compliance across the distribution chain: A deep dive into economic operators’ roles
  • 10:45 AM - 11:10 AM EST
    Sponsored Presentation: No hype, just help: AI tools that support your daily regulatory workflow
  • 11:00 AM - 11:30 AM EST
    RAPS Central Board Round Up: Is Quality Part of your Organization’s DNA?
  • 11:00 AM - 12:00 PM EST
    RAPS Certification Lounge: Ask RAC & RCC Holders: Get your Certification Questions Answered
  • 11:15 AM - 11:30 AM EST
    Student Capstone Presentation: Implementing E-Labeling in Pharma and Medical Devices: A Step-by-Step Guide
  • 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: Global regulatory strategy: Change management
  • 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: RI impact: How AI and systematic reviews deliver measurable and actionable regulatory intelligence
  • 11:30 AM - 12:30 PM EST
    Speed Mentoring in Career Central, Exhibit Hall (Sign-Up Required)
  • 11:30 AM - 12:30 PM EST
    Writing for RAPS
  • 11:30 AM - 1:00 PM EST
    Networking Lunch in the Exhibit Hall
  • 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: Implementing flexibility and efficiency in labeling change management
  • 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 - 12:25 PM EST
    (repeat) Submission Gaps in Medical Devices in EU and How to Resolve
  • 11:55 AM - 12:25 PM EST
    Continuing the Conversation: Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials
  • 12:00 PM - 12:30 PM EST
    Career Central Stage: Introducing a New Credential: How the FRA Empowers New Professionals
  • 12:00 PM - 12:30 PM EST
    RAPS Central Board Round Up: Ask Me Anything!
  • 1:00 PM - 2:00 PM EST
    A Case Study on Health Equity Through the Lens of Pulse Oximetry
  • 1:00 PM - 2:00 PM EST
    Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products
  • 1:00 PM - 2:00 PM EST
    Engineering Safety and Effectiveness for Regulatory Excellence in Drug-Device Combination Products
  • 1:00 PM - 2:00 PM EST
    Enhancing Charisma and Influence: Non-Verbal and Digital Body Language for Regulatory Professionals
  • 1:00 PM - 2:00 PM EST
    Global Oncology Drug Advisory Mechanisms: Insights from FDA’s ODAC and International Counterparts
  • 1:00 PM - 2:00 PM EST
    Optimizing Strategies to Support Implementation of the Global Post-Approval Changes in the Product Life Cycle
  • 1:00 PM - 2:00 PM EST
    Practical Tips for Speeding Up Postmarket Innovation with Predetermined Change Control Plans (PCCPs) Beyond AI/ML
  • 1:00 PM - 2:00 PM EST
    Structured Dialogues: 10 Effective Topics to Engage With Your Notified Body
  • 2:00 PM - 2:25 PM EST
    Student Capstone Poster Display: Digital Healthcare Platforms and Artificial Intelligence in Global Regulatory Compliance for Medical Devices
  • 2:00 PM - 2:25 PM EST
    Student Capstone Poster Display: Is More Technology Always Better? Participant Burden Considerations in Clinical Trials
  • 2:00 PM - 2:30 PM EST
    Refreshment Break in the Exhibit Hall
  • 2:00 PM - 3:15 PM EST
    Exclusive Exhibit Hall Hours: Networking & Presentations
  • 2:00 PM - 3:15 PM EST
    Pawsitive Reinforcement
  • 2:00 PM - 3:15 PM EST
    RAPS Certification Lounge: Exclusive Lounge Hours for RAC & RCC Holders
  • 2:00 PM - 3:15 PM EST
    RAPS Chapter/LNG Meet & Greets in Career Central
  • 2:05 PM - 2:35 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
  • 2:05 PM - 2:35 PM EST
    (repeat) Submission Gaps in Medical Devices in US and How to Resolve
  • 2:10 PM - 2:35 PM EST
    Sponsored Presentation: Clinical evaluation reports: Notified Body expectations
  • 2:30 PM - 3:00 PM EST
    RAPS Central Board Round Up: Ethical Challenges in Regulatory
  • 2:30 PM - 3:15 PM EST
    Career Central Stage: Convergence Is Over - Now What? How to Create Lasting Professional Relationships
  • 2:40 PM - 3:10 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
  • 2:40 PM - 3:10 PM EST
    Continuing the Conversation: The Convergence of Regulatory and Politics: How the President and Congress will Affect FDA Regulation
  • 3:15 PM - 4:15 PM EST
    Accelerating Regulatory Discussion on Digital Health Devices
  • 3:15 PM - 4:15 PM EST
    Can GenAI Help Regulatory Teams Scale Up Their Operations? Pitfalls and Best Practices
  • 3:15 PM - 4:15 PM EST
    China Drug Regulatory Pathways: 2025 Major Updates and Deep-Dive
  • 3:15 PM - 4:15 PM EST
    Cybersecurity
  • 3:15 PM - 4:15 PM EST
    EUDAMED Implementation
  • 3:15 PM - 4:15 PM EST
    Is it time for a new Patient Experience Data section in product labeling?
  • 3:15 PM - 4:15 PM EST
    Recent Developments in Nitrosamines
  • 4:30 PM - 5:30 PM EST
    Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges One Year On
  • 4:30 PM - 5:30 PM EST
    Emerging Regulatory Trends, Pre-Marketing Submissions
  • 4:30 PM - 5:30 PM EST
    Expanding Global Biosimilar Access: Converging Regulatory Approaches with Analytical Insights
  • 4:30 PM - 5:30 PM EST
    Pediatric Regulatory Strategies and Trends in the EU and US
  • 4:30 PM - 5:30 PM EST
    QSR to QMSR Shift: Best Practices, Pitfalls & Compliance Strategies
  • 4:30 PM - 5:30 PM EST
    Scaling the Pond: Routes to Market in the UK and Switzerland
  • 4:30 PM - 5:30 PM EST
    Transforming Medication Access: Using technology and FDA’s New NDA Pathway Empowers Patient Options
  • 6:30 PM - 9:30 PM EST
    RAPS Convergence 2025 Closing Party Celebration at Heinz History Center