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Requires Pre-Registration or Sign-up
Requires Pre-Registration or Sign-up
Additional Registration Fee
Additional Registration Fee
Invitation Only
Invitation Only
Student Program
Student Program
Networking Opportunity
Networking Opportunity
RAPS Focus Area
RAPS Focus Area

Full Schedule

Full Schedule

  • Wednesday, October 4, 2023
  • 12:00 AM – 11:59 PM EDT
    Wellness at RAPS Convergence
  • 6:30 AM – 4:30 PM EDT
    Speaker Ready Room Open
  • 6:30 AM – 6:00 PM EDT
    Registration Open
  • 7:00 AM – 8:00 AM EDT
    Community Gathering & Continental Breakfast
  • 7:00 AM – 6:00 PM EDT
    Event App Support Desk Hours
  • 7:30 AM – 6:00 PM EDT
    RAPS Store Hours
  • 7:30 AM – 7:00 PM EDT
    Press Office Hours
  • 8:00 AM – 9:15 AM EDT
    Combination Products - New
  • 8:00 AM – 9:15 AM EDT
    Decoding Orphan Drug development: Bridging boundaries and thinking “outside the box”
  • 8:00 AM – 9:15 AM EDT
    EU-MDR Implementation: Latest News
  • 8:00 AM – 9:15 AM EDT
    Health Authority Forum: European Medicines Agency (EMA)
  • 8:00 AM – 9:15 AM EDT
    Patient Perspective - New
  • 8:00 AM – 9:15 AM EDT
    Risk Management – The Importance of Lifecycle Traceability
  • 8:00 AM – 9:15 AM EDT
    Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs
  • 9:30 AM – 10:30 AM EDT
    Plenary Session: Regulatory, Policy, and Societal Challenges of Psychedelics and the Path Forward
  • 10:30 AM – 11:00 AM EDT
    Coffee Break in the Exhibit Hall
  • 10:30 AM – 2:30 PM EDT
    Certification Lounge Hours
  • 10:30 AM – 2:30 PM EDT
    Exhibit Hall Hours
  • 10:30 AM – 2:30 PM EDT
    Headshot Lounge
  • 10:30 AM – 2:30 PM EDT
    Regulatory Cares Community Giveback
  • 10:30 AM – 2:30 PM EDT
    Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and Cemiplimab
  • 10:30 AM – 2:30 PM EDT
    Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab
  • 10:45 AM – 11:10 AM EDT
    Sponsored Presentation: A combination products perspective on IDMP implementation
  • 10:45 AM – 11:10 AM EDT
    Sponsored Presentation: Considerations for Successful PMCF Survey Implementation
  • 10:45 AM – 11:10 AM EDT
    Sponsored Presentation: Talent Management Strategies: The Hiring and the Hired
  • 10:45 AM – 11:15 AM EDT
    "How soon can I implement this?"Navigating FDA Submissions and Review Logistics: A One-Stop Guide
  • 10:45 AM – 11:15 AM EDT
    A Roadmap of Expedited Pathways in Europe - the Fast for the Curious
  • 10:45 AM – 11:15 AM EDT
    Biosimilar Regulations in Middle East - Challenges and Proposed Solutions
  • 10:45 AM – 11:15 AM EDT
    eCTD Module 3, How Much Detail Do I Submit?
  • 11:00 AM – 11:15 AM EDT
    Student Capstone Oral Presentation: Patient-Focused Drug Development and the 21st Century Cures Act: A Qualitative Case-Control Study
  • 11:00 AM – 11:30 AM EDT
    RAPS BOD Roundtable: Emerging Regulatory Trends
  • 11:15 AM – 11:40 AM EDT
    How AI will Power the Future of Proofreading in Pharma
  • 11:15 AM – 11:40 AM EDT
    Sponsored Presentation: Improve Time to Value with Integrated Product and Regulatory Data
  • 11:15 AM – 11:40 AM EDT
    Sponsored Presentation: Using AI/ML technology to improve regulatory efficiency by 60%
  • 11:15 AM – 12:00 PM EDT
    Chapter Meet and Greet at Career Central
  • 11:25 AM – 11:55 AM EDT
    5 ways that an RA department will be impacted by IDMP data standards
  • 11:25 AM – 11:55 AM EDT
    Enabling earlier access to medicines in Latin America by rationalizing legalization / apostillation requirements
  • 11:25 AM – 11:55 AM EDT
    Q&A on the EU General Pharmaceutical Legislation Revision
  • 11:25 AM – 11:55 AM EDT
    Regulatory strategy for market entry to China for drug master filing (DMF)
  • 11:45 AM – 12:00 PM EDT
    Student Capstone oral presentation: Australia market access strategy of novel drug with companion diagnostic test kit for breast cancer
  • 11:45 AM – 12:10 PM EDT
    Sponsored Presentation: Improving Operational Excellence and Patient Safety with MDDAP
  • 11:45 AM – 12:10 PM EDT
    Sponsored Presentation: Steps to prepare for effective EUDAMED product Data Syndication
  • 11:45 AM – 12:10 PM EDT
    Sponsored Presentation: UDI Essentials for Regulatory Affairs Teams
  • 11:45 AM – 12:15 PM EDT
    RAPS BOD Roundtable: I Am Regulatory
  • 12:00 PM – 1:00 PM EDT
    RAPS BOD Roundtable: Volunteering
  • 12:00 PM – 1:30 PM EDT
    Networking Lunch in Exhibit Hall
  • 12:05 PM – 12:35 PM EDT
    Medical Device EU MDR lessons learned with two different notified bodies
  • 12:05 PM – 12:35 PM EDT
    Methodologies for building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/ML
  • 12:05 PM – 12:35 PM EDT
    Sourcing Other Study Drugs for Global Clinical Trials
  • 12:05 PM – 12:35 PM EDT
    Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation
  • 12:15 PM – 12:40 PM EDT
    Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the challenges, solutions, and best practices
  • 12:15 PM – 12:40 PM EDT
    Sponsored Presentation: How to Optimize a MDSAP/EU compliant QMS, including feedback on common issues
  • 12:15 PM – 12:40 PM EDT
    Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI
  • 12:45 PM – 1:10 PM EDT
    Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative
  • 12:45 PM – 1:10 PM EDT
    Sponsored Presentation: Unlocking China's Market: A Guide to Overcome Access Barriers for Medical Devices
  • 12:45 PM – 1:10 PM EDT
    Unveiling MoCRA: Revolutionizing Cosmetics Regulation and Empowering Manufacturers
  • 12:45 PM – 1:15 PM EDT
    Annex XVI State of Play
  • 12:45 PM – 1:15 PM EDT
    Career Central Presents: Get your Regulatory Compliance Certification (RCC): Introducing Two New Compliance Certifications
  • 12:45 PM – 1:15 PM EDT
    Getting it right the first time - Where regulatory and design intersect; accuracy/acceptance criteria
  • 12:45 PM – 1:15 PM EDT
    RAPS Store Stage: Meet the Authors - Regulation of Regenerative Medicines: A Global Perspective
  • 12:45 PM – 1:15 PM EDT
    Regulatory Intelligence Campfire Chat
  • 12:45 PM – 1:15 PM EDT
    US Combination Products Updates: What you need to know!
  • 12:45 PM – 1:45 PM EDT
    RAPS Fellows Speed Mentoring at Career Central (Sign-up Required)
  • 2:00 PM – 3:00 PM EDT
    Anatomy of a Tweet in a MedDev regulatory environment
  • 2:00 PM – 3:00 PM EDT
    Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
  • 2:00 PM – 3:00 PM EDT
    Drug Registration Pathways in China: 2023 Latest Updates
  • 2:00 PM – 3:00 PM EDT
    FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
  • 2:00 PM – 3:00 PM EDT
    FDA Forecast 2024: What pharmaceutical and biotech regulatory professionals can expect from FDA next year
  • 2:00 PM – 3:00 PM EDT
    Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them
  • 2:00 PM – 3:00 PM EDT
    Transforming Patient Engagement in Medical Technologies' evolving Regulatory Landscape
  • 2:00 PM – 3:00 PM EDT
    UDI & Global Supply Chain Compliance
  • 3:00 PM – 3:30 PM EDT
    Coffee & Refreshment Break
  • 3:30 PM – 4:30 PM EDT
    Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health Canada
  • 3:30 PM – 4:30 PM EDT
    Ensuring Patient Registries Support Regulatory Decision-Making
  • 3:30 PM – 4:30 PM EDT
    EU-MDR Notified Body Forum
  • 3:30 PM – 4:30 PM EDT
    FDA Forecast 2024: What device and diagnostics regulatory professionals can expect from FDA next year
  • 3:30 PM – 4:30 PM EDT
    Industry Experience with Implementing ICH Q12 in US and Canada
  • 3:30 PM – 4:30 PM EDT
    Lifecycle of a device, difference between SaMD & AI, pre-post market
  • 3:30 PM – 4:30 PM EDT
    Navigating global regulatory frameworks for cell and gene therapy development
  • 3:30 PM – 4:30 PM EDT
    The Future of Regulatory Affairs In An Everchanging World
  • 4:45 PM – 5:45 PM EDT
    Challenges in implementation of IVDR requirements for CDx clinical performance studies
  • 4:45 PM – 5:45 PM EDT
    Efficient Product Master Data Management: FDA , EUDAMED, and other Medical DeviceRegistry submission/Syndication.
  • 4:45 PM – 5:45 PM EDT
    FDA proposed ACNU NDA, a new era for patient access and commercial lifecycle management strategies
  • 4:45 PM – 5:45 PM EDT
    Health Authority Forum: CBER & CDER - FDA’s Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER)
  • 4:45 PM – 5:45 PM EDT
    Making an impact to bring further Diversity and inclusion in Clinical Research
  • 4:45 PM – 5:45 PM EDT
    Real-world evidence and Expert Panel opinions - discussion between a consultant and 3 Notified Bodies
  • 4:45 PM – 5:45 PM EDT
    Regulatory Opportunities and Challenges with mRNA Technology – Lessons Learned from the COVID-19 Pandemic
  • 4:45 PM – 5:45 PM EDT
    When to “Factor” in Human Factors
  • 6:00 PM – 7:15 PM EDT
    Honoring Excellence: RAPS 2023 Awards Celebration by Invitation Only
  • 6:00 PM – 9:00 PM EDT
    Dine-Arounds
  • 7:30 PM – 10:00 PM EDT
    SOLD OUT - Convergence Networking Party (ticket required)