Skip to main content


Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Ticketed Event
Ticketed Event
Sponsored Presentation
Sponsored Presentation
Learning Level: Foundational
Learning Level: Foundational
New Exhibitor
New Exhibitor
Networking Event
Networking Event
Enterprise Network Member
Enterprise Network Member
Learning Level: Expert
Learning Level: Expert
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Intermediate
Learning Level: Intermediate

Full Schedule

Full Schedule

  • Monday, May 6, 2024
  • 08:00 – 18:00 CEST
    Registration Hours
  • 08:30 – 16:00 CEST
    Pre -Conference Workshop: EUDAMED
  • 08:30 – 16:00 CEST
    Pre-Conference Workshop: Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Regulation’s Technical Documentation Requirements and how to integrate them into an MDR Submission
  • 08:30 – 16:00 CEST
    Pre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to Execution
  • 08:30 – 16:00 CEST
    Pre-Conference Workshop: IVDR Technical Documentation
  • 08:30 – 16:00 CEST
    Pre-Conference Workshop: Start-Ups
  • 08:30 – 16:00 CEST
    Pre-Conference Workshop: What does it take from CE to MDSAP?
  • 14:00 – 16:00 CEST
    Career Development for Students
  • 16:30 – 18:30 CEST
    RAPS Euro Convergence 2024 - Welcome & Opening Plenary Session
  • 18:30 – 19:30 CEST
    Opening Reception in Exhibit Hall
  • Tuesday, May 7, 2024
  • 08:00 – 18:00 CEST
    Registration Hours
  • 08:30 – 09:30 CEST
    Biocompatibility: ‘Substances of concern’ – Have you checked? GSPR 10.4 a practical guide
  • 08:30 – 09:30 CEST
    Kick-off MDR panel
  • 08:30 – 09:30 CEST
    Patient Access
  • 08:30 – 09:30 CEST
    Registration of radiopharmaceuticals in the EU
  • 08:30 – 09:30 CEST
    The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessments .
  • 08:30 – 09:30 CEST
    The IVDR clock is ticking... but should there be alarm?
  • 09:50 – 10:50 CEST
    Artificial Intelligence in IVDR
  • 09:50 – 10:50 CEST
    Clinical Evaluation
  • 09:50 – 10:50 CEST
    Clinical Performance Studies under IVDR
  • 09:50 – 10:50 CEST
    Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions
  • 09:50 – 10:50 CEST
    New EU Pharma Legislation
  • 09:50 – 10:50 CEST
    Regulatory Leadership: Digitization & Digital Health - There is NO turning back!
  • 10:50 – 11:30 CEST
    Coffee Break and Posters in the Exhibit Hall
  • 11:30 – 12:00 CEST
    Global IVDs
  • 11:30 – 12:30 CEST
    AI Act: The MDR and the AI Act: A match made in heaven or the odd couple?
  • 11:30 – 12:30 CEST
    Career Development: Forging a Career Path in the Age of Technology
  • 11:30 – 12:30 CEST
    Key trends impacting HTA and Regulatory interface
  • 11:30 – 12:30 CEST
    The MDR hurdle for startups and innovation - and strategies to overcome it
  • 11:30 – 12:30 CEST
    UKCA
  • 12:00 – 12:30 CEST
    Global IVDs
  • 12:30 – 13:00 CEST
    Solution Circle: RA-GPT - the future of the regulatory profession
  • 12:30 – 13:00 CEST
    Solution Circle: What can manufacturers learn from effective PMS/PMPF strategies to strengthen their Clinical Evidence with the IVDR transition deadline approaching?
  • 12:30 – 13:45 CEST
    Networking Lunch in Exhibit Hall
  • 13:10 – 13:40 CEST
    Sponsored Presentations
  • 13:15 – 13:45 CEST
    Solution Circle: How to distinguish general and specific PMCF activities
  • 13:15 – 13:45 CEST
    Solution Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) according to the IVDR
  • 13:45 – 14:45 CEST
    Finding value in post market clinical data collection
  • 13:45 – 14:45 CEST
    IVDR Class D Devices – Latest Updates & Experience
  • 13:45 – 14:45 CEST
    Meeting EMA and FDA: Formal and informal pathways, in search of alignment
  • 13:45 – 14:45 CEST
    Randomized Clinical Trials vs. Validation Cohort studies of AI/ML-based SaMDs: what are the differences and guidelines for appraisal of the clinical evidence?
  • 13:45 – 14:45 CEST
    Standards and Compliance
  • 13:45 – 14:45 CEST
    Unveiling Insights: Navigating the public disclosure of clinical trials in an evolving industry
  • 15:05 – 16:05 CEST
    CDx or not CDx that is the Question
  • 15:05 – 16:05 CEST
    Combination Products
  • 15:05 – 16:05 CEST
    From China to WHO: Strategies & Updates to Accelerate China & WHO Drug Approvals and Master Files
  • 15:05 – 16:05 CEST
    MDR Art. 117 for Combination Products. Are the challenges solved now? State of Play from EMA, NB and Industry
  • 15:05 – 16:05 CEST
    Post-market requirements: Keeping PSUR and SSCP up to date
  • 15:05 – 16:05 CEST
    Securing AI solutions in MedTech products
  • 15:05 – 16:05 CEST
    Use of Real World Evidence
  • 16:05 – 16:45 CEST
    Coffee Break in the Exhibit Hall
  • 16:10 – 16:40 CEST
    Sponsored Presentations
  • 16:45 – 17:45 CEST
    Biologics & Biosimilars
  • 16:45 – 17:45 CEST
    Don’t get orphaned: how to be novel in the IVDR environment.
  • 16:45 – 17:45 CEST
    Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals alike
  • 16:45 – 17:45 CEST
    Pre-clinical evaluations and clinical investigations. Strategizing towards efficiency and new approaches including in silico methods
  • 16:45 – 17:45 CEST
    Regulators and Industry perspective on Use of Artificial Intelligence in the Drug Development Lifecycle
  • 16:45 – 17:45 CEST
    Scientific Advisory Panel 
  • 18:30 – 22:00 CEST
    Euro Convergence Networking Dinner (ticket required)
  • Wednesday, May 8, 2024
  • 08:00 – 16:00 CEST
    Registration Hours
  • 08:30 – 09:45 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 09:45 – 10:25 CEST
    Coffee Break in the Exhibit Hall
  • 10:25 – 11:25 CEST
    Application of article 61(10), non-clinical data, for SaMD and AI
  • 10:25 – 11:25 CEST
    Career Development: LIVE LinkedIn review Session
  • 10:25 – 11:25 CEST
    CTA with Devices
  • 10:25 – 11:25 CEST
    Global IVDs
  • 10:25 – 11:25 CEST
    Risk Management
  • 10:25 – 11:25 CEST
    The paradigm shift in the EU market approval of devices and IVDs - a hot potato?!
  • 11:45 – 12:45 CEST
    Clinical Evaluation
  • 11:45 – 12:45 CEST
    Data Security & Digital Health
  • 11:45 – 12:45 CEST
    Environmental Regulation
  • 11:45 – 12:45 CEST
    Maintaining Compliance: IVDR Post-Certification Activities
  • 11:45 – 12:45 CEST
    Patient-Centric Endpoints and Use of Digital Health Technologies
  • 11:45 – 12:45 CEST
    Supply Chain/Shortage
  • 12:25 – 13:55 CEST
    Sponsored Presentations
  • 12:30 – 13:00 CEST
    Solution Circle: Cyber Security – Pitfalls for IVDR Technical File Submission
  • 12:30 – 13:00 CEST
    Solution Circle: Essentials of EU Regulatory Intelligence; overview of key aspects of regulatory intelligence
  • 12:30 – 13:00 CEST
    Solution Circle: How does the SSCP improve patient safety in less than 100 pages?
  • 12:45 – 14:00 CEST
    Networking Lunch in Exhibit Hall
  • 13:15 – 13:45 CEST
    Solution Circle: Effective Strategies When Approaching Regulatory Due Diligence under the MDR
  • 13:15 – 13:45 CEST
    Solution Circle: Intended purpose, device classification, NB codes and corresponding types of devices /sampling TD under the IVDR
  • 13:15 – 13:45 CEST
    Solution Circle:Effective Strategies for High-Quality Clinical Data Collection through Post-market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
  • 14:00 – 15:00 CEST
    International Regulatory Frameworks to Accelerate Orphan Drug Registrations
  • 14:00 – 15:00 CEST
    Core Data Sheets
  • 14:00 – 15:00 CEST
    Cybersecurity
  • 14:00 – 15:00 CEST
    Experience gain from implementing Article 5(5) of the IVDR in a network of European Laboratories
  • 14:00 – 15:00 CEST
    IMDRF Coding
  • 14:00 – 15:00 CEST
    Post Market Clinical Studies
  • 15:00 – 15:40 CEST
    Coffee Break in the Exhibit Hall
  • 15:40 – 16:40 CEST
    An overview of AI, Software and Cybersecurity regulations in Asia
  • 15:40 – 16:40 CEST
    Biologics & Biosimilars
  • 15:40 – 16:40 CEST
    IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?
  • 15:40 – 16:40 CEST
    Orphan Devices
  • 15:40 – 16:40 CEST
    Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a case study
  • 15:40 – 16:40 CEST
    Structured Dialogue
  • 16:40 – 17:15 CEST
    Closing Remarks & Farewell Toast