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Full Schedule

Full Schedule

  • Thursday, September 9, 2021
  • 9:00 AM – 12:30 PM
    Pre-Conference Workshop: Drug Development in EU: Regulatory Standards, Support and New Approaches - Part 1
  • 1:00 PM – 8:00 PM
    Pre-Conference Workshop: Japan Regulatory Essentials of MDs/IVDs - Seeking Innovation into the Regulation
  • Friday, September 10, 2021
  • 9:00 AM – 12:00 PM
    Pre-Conference Workshop: Drug Development in EU: Regulatory Standards, Support and New Approaches - Part 2
  • 9:00 AM – 5:00 PM
    Pre-Conference Workshop: Global Regulatory Strategy
  • Sunday, September 12, 2021
  • 12:00 PM – 1:00 PM
    Opening Plenary Session
  • 1:00 PM – 1:30 PM
    Opening Plenary Discussion Groups
  • 1:30 PM – 2:30 PM
    Welcome Reception
  • Monday, September 13, 2021
  • 8:15 AM – 8:45 AM
    Wellness Experience
  • 9:00 AM – 9:30 AM
    Plenary Session
  • 9:00 AM – 4:45 PM
    Sponsor Solutions - Visit Sponsor Booths
  • 9:30 AM – 9:45 AM
    Plenary Meet the Speakers
  • 9:45 AM – 10:00 AM
    Visit Sponsors - Brain Break
  • 10:00 AM – 10:30 AM
    Regulatory Affairs and Merger & Acquisition – Lessons learned bringing businesses together
  • 10:00 AM – 10:30 AM
    Regulatory Strategy or Clinical Strategy- Where they converge and where they diverge
  • 10:00 AM – 11:00 AM
    Cell/Gene Therapy, Part 1
  • 10:00 AM – 11:00 AM
    Conversations that Matter: Interactions with Health Authorities (FDA and EMA Collaboration)
  • 10:00 AM – 11:00 AM
    Health Authority Forum: Japan
  • 10:00 AM – 11:00 AM
    ICH Implementation: The Transition from Convergence to Harmonization
  • 10:00 AM – 11:00 AM
    ISO 10993 and Biocompatibility – Test or Not to Test?!
  • 10:00 AM – 11:00 AM
    Leadership : Considerations for Being a Remote Successful Leader in 2021 and Beyond
  • 10:00 AM – 11:00 AM
    OTC's: Proprietary Name Assessment – Special Considerations for OTC Drugs
  • 10:00 AM – 11:00 AM
    Points for Conducting an Effective Global Clinical Trial through Experiences in US-Japan HBD Collaborative Activities
  • 10:00 AM – 11:00 AM
    Regulatory Advances in Digital Health Worldwide in digital health worldwide
  • 11:00 AM – 11:15 AM
    Meet the Speaker Sessions
  • 11:15 AM – 12:00 PM
    Sponsored Presentations
  • 11:15 AM – 12:00 PM
    Visit Sponsors - Brain Break
  • 12:00 PM – 12:30 PM
    Collaborative Communication of Changes in the Regulatory Environment
  • 12:00 PM – 12:30 PM
    Getting the Most out of your Pre-Submission Meeting with FDA
  • 12:00 PM – 1:15 PM
    COVID Treatments - COVID Treatments - lessons learned
  • 12:00 PM – 1:15 PM
    Elevating the Role of PROs & Patient Preference Information in Regulatory Decision Making
  • 12:00 PM – 1:15 PM
    EU MDR/IVDR Opening Panel
  • 12:00 PM – 1:15 PM
    Expedited Designations and Pathways
  • 12:00 PM – 1:15 PM
    Health Authority Forum: CDRH
  • 12:00 PM – 1:15 PM
    Negotiation Skills: Mastering Career Negotiations for Success
  • 12:00 PM – 1:15 PM
    Step Inside the Real World”: Real-world Evidence Strategies in FDA Device Applications
  • 12:00 PM – 1:15 PM
    Technical Requirements for Preparation of AI Technical Documents and Cybersecurity Standards
  • 1:15 PM – 1:30 PM
    Meet the Speaker Sessions
  • 1:30 PM – 2:15 PM
    Lunch Break - Visit Sponsors
  • 1:30 PM – 2:15 PM
    RAPS Chapter/Local Networking Group Meet & Greets
  • 2:15 PM – 3:00 PM
    Sponsored Presentations
  • 3:00 PM – 3:30 PM
    Change is on the Horizon for MRI Safety Labeling of Medical Devices
  • 3:00 PM – 3:30 PM
    Powerful Speed Networking Resulting in Meaningful Information Sharing
  • 3:00 PM – 4:00 PM
    Artificial Intelligence: Bias and Explainability in Algorithms
  • 3:00 PM – 4:00 PM
    Clinical Evaluation - Part 1
  • 3:00 PM – 4:00 PM
    Decentralized Trials - Crisis Met, Future Forward
  • 3:00 PM – 4:00 PM
    FDA ASCA Pilot Program
  • 3:00 PM – 4:00 PM
    Health Authority Forum: CBER
  • 3:00 PM – 4:00 PM
    Supply Chain - Drug Shortage: US Drug Shortage Regulatory Requirements – FDA and Industry Perspectives
  • 3:00 PM – 4:00 PM
    The Impact of a REMS Release- A Global View
  • 3:00 PM – 4:00 PM
    Working at the FDA
  • 4:00 PM – 4:15 PM
    Meet the Speaker Sessions
  • 4:15 PM – 4:45 PM
    Monday Wrap Up Experience
  • Tuesday, September 14, 2021
  • 8:15 AM – 8:45 AM
    Wellness Experience
  • 9:00 AM – 9:30 AM
    Plenary Session
  • 9:00 AM – 4:45 PM
    Sponsor Solutions - Visit Sponsor Booths
  • 9:30 AM – 9:45 AM
    Plenary Session - Meet the Speakers
  • 9:45 AM – 10:00 AM
    Visit Sponsors - Brain Break
  • 10:00 AM – 10:30 AM
    Ensuring Supply Continuity Through Regulatory Strategy
  • 10:00 AM – 10:30 AM
    TPLC Approach for New Product Development and Sustaining Engineering: Making the Most of Postmarket Data
  • 10:00 AM – 11:00 AM
    Data Transparency : Begin With the End in Mind: Planning for Clinical Trial Transparency and Disclosure Requirements
  • 10:00 AM – 11:00 AM
    Career Development and Career Changes - Being a Regulatory Chief of Staff
  • 10:00 AM – 11:00 AM
    China Regulatory 2021 Deep-Dive: Major Updates, IVD regulatory landscape, Evolving Digital Health Frameworks
  • 10:00 AM – 11:00 AM
    Clinical Trial Diversity - A Global View
  • 10:00 AM – 11:00 AM
    Drug Competition and Market Entry : Regulatory Considerations and Commercial Challenges
  • 10:00 AM – 11:00 AM
    Health Authority Forum: CDER
  • 10:00 AM – 11:00 AM
    Regulatory Framework to Support Innovation: Preventing and Resolving Disputes with FDA to Support Medical Device Innovation
  • 10:00 AM – 11:00 AM
    UK: Challenges and Opportunities with the New United Kingdom Conformity Assessment (UKCA) Process
  • 11:00 AM – 11:15 AM
    Meet the Speaker Sessions
  • 11:15 AM – 12:00 PM
    Sponsored Presentations
  • 11:15 AM – 12:00 PM
    Visit Sponsors - Brain Break
  • 12:00 PM – 12:30 PM
    Companion Diagnostics (CDx) from US to Global: Current Developments and Best Practices
  • 12:00 PM – 12:30 PM
    LATAM Regulatory & Access: Reliance and Innovation Strategic Pathways
  • 12:00 PM – 12:30 PM
    RAPS Volunteers Converge!
  • 12:00 PM – 1:15 PM
    Building Regulatory Efficiencies Through Expedited, Reliance and Collaboration Pathways
  • 12:00 PM – 1:15 PM
    Clinical Evaluation - Part 2
  • 12:00 PM – 1:15 PM
    Drawing the Signal from the Noise in RWE for Regulatory Use
  • 12:00 PM – 1:15 PM
    Health Authority Forum: Europe Medical Devices
  • 12:00 PM – 1:15 PM
    Pediatric Drug Development: Increasing Success and Overcoming Obstacles
  • 12:00 PM – 1:15 PM
    Postmarketing Clinical Follow-Up (PMCF)
  • 12:00 PM – 1:15 PM
    Preparing for FDA Interactions Across the Drug Development Lifecycle: How to Positively Impact the Pathway to Approval by Engaging with the FDA Early and Often
  • 12:00 PM – 1:15 PM
    Risk Management and Usability: Know the Ropes and Get Safely Through the Product Life Cycle
  • 1:15 PM – 1:30 PM
    Meet the Speaker Sessions
  • 1:30 PM – 2:15 PM
    Lunch Break - Visit Sponsors - Brain Break
  • 1:30 PM – 2:15 PM
    RAPS Chapter/Local Network Group Meet & Greets
  • 2:05 PM – 3:00 PM
    Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices
  • 2:15 PM – 3:00 PM
    Sponsored Presentations
  • 3:00 PM – 3:30 PM
    Benchmarking your dossier preparation process – How does your organization compare?
  • 3:00 PM – 3:30 PM
    Ethylene Oxide Sterilization Panel: EO Reduction Methodology and Global Regulatory Strategies and Pathways
  • 3:00 PM – 3:30 PM
    Strategy Under Uncertainty - Approaches to Increasing the Probability of Regulatory Success
  • 3:00 PM – 4:00 PM
    Accelerating Drug Development a, the Power of Pilots & Lessons Learned From Other Drivers of Innovation
  • 3:00 PM – 4:00 PM
    Cell/Gene Therapy -- Innovative Technologies (Part 2)
  • 3:00 PM – 4:00 PM
    Combination Products: Implementing Article 117 MDR Requirements Among Stake Holders
  • 3:00 PM – 4:00 PM
    Companion Diagnostics: EU IVDR vs FDA - Convergence and Divergence
  • 3:00 PM – 4:00 PM
    Performance Evaluation and Clinical Evidence
  • 3:00 PM – 4:00 PM
    Ready, Set, Launch! Go-to-Market Advertising and Promotion Strategies
  • 3:00 PM – 4:00 PM
    Regulatory Intelligence: - Hiding in Plain Sight: Finding RWE Precedent in Public Information
  • 4:00 PM – 4:15 PM
    Meet the Speakers Sessions
  • 4:15 PM – 4:45 PM
    Tuesday Wrap Up Experience
  • Wednesday, September 15, 2021
  • 8:15 AM – 8:45 AM
    Wellness Experience
  • 9:00 AM – 9:30 AM
    Solution Circles
  • 9:00 AM – 10:00 AM
    ArtificialUsing Intelligent Automation and Advanced Technology to Enhance Regulatory Performance
  • 9:00 AM – 10:00 AM
    BREXIT - Licensing Opportunities and Challenges to Overcome
  • 9:00 AM – 10:00 AM
    Conversations that Matter: Interactions with Health Authorities (US and EU Combination Products)
  • 9:00 AM – 10:00 AM
    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
    Navigating Europe and China UDI
  • 9:00 AM – 10:00 AM
    Regulatory Strategy: Fostering Cross-Functional Team Success
  • 9:00 AM – 10:00 AM
    The Periodic Safety Update Report - What You Really Need to Know in 45 Minutes!
  • 9:00 AM – 10:00 AM
    US Policy: What has the New Biden Administration Meant for the FDA and its Regulation of Industry?
  • 9:00 AM – 1:30 PM
    Sponsor Solutions - Visit Sponsors
  • 10:00 AM – 10:15 AM
    Meet the Speaker Sessions
  • 10:00 AM – 10:30 AM
    Early Experience with Technical Documentation Assessment of Class III Orthopedic Devices Under the MDR
  • 10:00 AM – 10:30 AM
    Patient Engagement During Drug Development: Tackling the Challenges
  • 10:15 AM – 11:00 AM
    Sponsored Presentations
  • 10:15 AM – 11:00 AM
    Visit Sponsors - Brain Break
  • 11:00 AM – 11:30 AM
    Solution Circles
  • 11:00 AM – 12:00 PM
    Crisis Management :Being a Regulatory Professional During a Pandemic: Professional Reflections and Lessons Learned
  • 11:00 AM – 12:00 PM
    How to Tackle the Biggest Challenges of SSCPs
  • 11:00 AM – 12:00 PM
    Lessons Learned: EU Continued Market Access – How to be Finished before 2024
  • 11:00 AM – 12:00 PM
    Orphan Drug / Rare Diseases
  • 11:00 AM – 12:00 PM
    Recent Developments in EU Regulations: Implementation of the EU MDR Requirements for Economic Operators
  • 11:00 AM – 12:00 PM
    Remote Inspections – Towards a New Way of Working
  • 11:00 AM – 12:00 PM
    The Secret Life of a NDC # - Regulatory, Safety, and Commercial Insights
  • 12:00 PM – 12:15 PM
    Meet the Speakers Sessions
  • 12:00 PM – 12:30 PM
    How to best present yourself as a candidate for recruitment
  • 12:00 PM – 12:30 PM
    Improving the Recall Process; Increasing Patient Safety while Reducing Costs
  • 12:15 PM – 12:45 PM
    Convergence 2021 Closing
  • 12:45 PM – 1:15 PM
    Wednesday Wrap Up Experience