Skip to main content


Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Full Schedule

Full Schedule

  • Wednesday, September 15, 2021
  • 8:15 AM – 8:45 AM EST
    Wellness Experience: 30-Minute Chair Yoga
  • 9:00 AM – 9:30 AM EST
    Early Experience with Technical Documentation Assessment of Class III Orthopedic Devices Under the MDR
  • 9:00 AM – 9:30 AM EST
    FIRST LOOK: 2021 Report on The Global Regulatory Affairs Professionals Workforce
  • 9:00 AM – 9:30 AM EST
    Patient Engagement During Drug Development: Tackling the Challenges
  • 9:00 AM – 10:00 AM EST
    ArtificialUsing Intelligent Automation and Advanced Technology to Enhance Regulatory Performance
  • 9:00 AM – 10:00 AM EST
    BREXIT - Licensing Opportunities and Challenges to Overcome
  • 9:00 AM – 10:00 AM EST
    Conversations That Matter: Interactions with Health Authorities
  • 9:00 AM – 10:00 AM EST
    Fostering Cross-functional Team Success with Project Management and Alliance Management Best Practices
  • 9:00 AM – 10:00 AM EST
    Good Clinical Practice for Clinical Performance Studies in IVDs, and Performance Evaluation Process and the Performance Evaluation Report (PER)
  • 9:00 AM – 10:00 AM EST
    Navigating Europe and China UDI
  • 9:00 AM – 10:00 AM EST
    The Periodic Safety Update Report - What You Really Need to Know in 45 Minutes!
  • 9:00 AM – 10:00 AM EST
    US Policy: What has the New Biden Administration Meant for the FDA and its Regulation of Industry?
  • 9:00 AM – 1:30 PM EST
    Sponsor Solutions - Visit Sponsors
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: BREXIT
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: Good Clinical Practice for Clinical Performance Studies in Ivds
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: Navigating Europe and China UDI
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: Regulatory Strategy: Fostering Cross-functional Team Success
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: The Periodic Safety Update Report
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: US Policy
  • 10:00 AM – 10:15 AM EST
    Meet the Speakers: Using Intelligent Automation and Advanced Technology to Enhance Regulatory Performance
  • 10:15 AM – 11:00 AM EST
    Meet and Greet: RAPS Colorado Chapter
  • 10:15 AM – 11:00 AM EST
    Meet the Authors: Fundamentals of International Regulatory Affairs, Fifth Edition, Section III: Medical Devices, Section IV: Biologics, Section V: Other Product Classifications
  • 10:15 AM – 11:00 AM EST
    Visit Sponsors - Brain Break
  • 11:00 AM – 11:30 AM EST
    Improving the Recall Process; Increasing Patient Safety while Reducing Costs
  • 11:00 AM – 12:00 PM EST
    Crisis Management: Being a Regulatory Professional During a Pandemic - Professional Reflections and Lessons Learned
  • 11:00 AM – 12:00 PM EST
    How to Tackle the Biggest Challenges of SSCPs
  • 11:00 AM – 12:00 PM EST
    Lessons Learned: EU Continued Market Access – How to be Finished before 2024
  • 11:00 AM – 12:00 PM EST
    Orphan Drug / Rare Diseases
  • 11:00 AM – 12:00 PM EST
    Recent Developments in EU Regulations: Implementation of the EU MDR Requirements for Economic Operators
  • 11:00 AM – 12:00 PM EST
    Remote Inspections – Towards a New Way of Working
  • 11:00 AM – 12:00 PM EST
    The Secret Life of a NDC # - Regulatory, Safety, and Commercial Insights
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: Crisis Management
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: How to Tackle the Biggest Challenges of Sscps
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: Lessons Learned: EU Continued Market Access
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: Orphan Drug / Rare Diseases
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: Recent Developments in EU Regulations
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: Remote Inspections
  • 12:00 PM – 12:15 PM EST
    Meet the Speakers: The Secret Life of a NDC #
  • 12:15 PM – 12:45 PM EST
    Convergence 2021 Closing
  • 12:45 PM – 1:15 PM EST
    Wednesday Wrap Up Experience