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Full Schedule

Full Schedule

  • Friday, May 7, 2021
  • 08:30 – 16:30 CEST
    Pre-Conference Workshop: Risk Management Under the EU Regulations for Medical Devices and In-vitro Diagnostics
  • 08:45 – 17:00 CEST
    Pre-Conference Workshop: Software as a Medical Device
  • 09:00 – 16:15 CEST
    Pre-Conference Workshop: Post-Market Reporting: MDR Article 88/Trending and PSUR
  • 09:00 – 17:00 CEST
    Pre-Conference Workshop: Clinical Studies in PMCF
  • Monday, May 10, 2021
  • 09:00 – 18:15 CEST
    Explore Sponsor Solutions - Visit Sponsor Booths
  • 09:00 – 18:15 CEST
    Poster Gallery Viewing
  • 09:30 – 11:30 CEST
    Opening Plenary Session - How to Make Sparks Fly
  • 10:00 – 19:00 CEST
    Explore Sponsor Solutions - Visit Sponsor Booths
  • 11:30 – 12:00 CEST
    Meet The Speakers - Plenary Opening Debate
  • 11:30 – 12:00 CEST
    Visit Sponsors - Brain Break
  • 12:00 – 13:00 CEST
    Clinical Evaluation
  • 12:00 – 13:00 CEST
    Drug-Device Combination Products Under MDR
  • 12:00 – 13:00 CEST
    Innovative Clinical Trial Design
  • 12:00 – 13:00 CEST
    Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
  • 13:00 – 13:15 CEST
    Meet The Speaker - Clinical Evaluation
  • 13:00 – 13:15 CEST
    Meet The Speaker - Drug-Device Combination Products Under MDR
  • 13:00 – 13:15 CEST
    Meet The Speaker - Innovative Clinical Trial Design
  • 13:00 – 13:15 CEST
    Meet The Speaker - Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
  • 13:15 – 14:00 CEST
    Lunch Break - Visit Sponsors - Brain Break
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Netherlands Chapter
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS UK Local Networking Group
  • 13:30 – 14:00 CEST
    Meet the Authors - Regulatory Intelligence
  • 14:00 – 14:45 CEST
    How Can Regulatory Intelligence Support Better Decision Making?
  • 14:00 – 14:45 CEST
    Medical Writing and Submission Compilation Made Easy: Technology Solutions from Regulatory Experts
  • 14:00 – 14:45 CEST
    Pre-IND Considerations - What to Do and When to Do it
  • 14:45 – 15:00 CEST
    Visit Sponsors - Brain Break
  • 15:00 – 15:30 CEST
    Accelerated Pathways: Bringing down Barriers to Supply Orphan Medicines in EU Markets with Very Low Patient Numbers
  • 15:00 – 16:00 CEST
    Functional Safety of Medical Devices
  • 15:00 – 16:00 CEST
    Global IVDs: Establishing an Effective Regulatory/Quality Program for Global Markets
  • 15:00 – 16:00 CEST
    How to Manage Grace Period?
  • 15:30 – 16:00 CEST
    Accelerated Pathways: Take International Collaboration in Paediatrics to the Next Level to Accelerate Access to Paediatric Medicines
  • 16:00 – 16:15 CEST
    Meet The Speaker - Accelerated Pathways
  • 16:00 – 16:15 CEST
    Meet The Speaker - Functional Safety
  • 16:00 – 16:15 CEST
    Meet The Speaker - Global IVDs
  • 16:00 – 16:15 CEST
    Meet The Speaker - How to Manage Grace Period?
  • 16:15 – 17:00 CEST
    Visit Sponsors - Brain Break
  • 17:00 – 17:30 CEST
    Global Regulatory Changes and Updates: Use of Real World Evidence in FDA Device Applications
  • 17:00 – 18:00 CEST
    Artificial Intelligence in MDR
  • 17:00 – 18:00 CEST
    Rest of the World
  • 17:00 – 18:30 CEST
    IVDR Debate - Regulation Changes
  • 17:30 – 18:00 CEST
    Global Regulatory Changes and Updates: Global Medical Device Regulatory Strategy
  • 18:00 – 18:15 CEST
    Combined Meet The Speaker - Global Regulatory Changes and Updates & Driving Successful Medical Device Product Launches
  • 18:00 – 18:15 CEST
    Meet The Speaker - Artificial Intelligence
  • 18:00 – 18:15 CEST
    Meet The Speaker - Rest of the World
  • 18:30 – 18:45 CEST
    Meet The Speaker - FIVDR Debate
  • Tuesday, May 11, 2021
  • 10:00 – 10:30 CEST
    Risk Management: Compliance with Risk Management Requirements in ISO 14155:2020 During Different Clinical Development Stages of Clinical Investigations for Medical Devices, Including SaMD
  • 10:00 – 11:00 CEST
    MDR Technical Overview: How to Navigate in the Waters of MDR implementation and Which icebergs to Avoid
  • 10:00 – 11:00 CEST
    Pandemic Readiness - Business Contingency
  • 10:00 – 11:00 CEST
    Pressure cooker: Fast Track to IVD-R Compliance
  • 10:00 – 17:00 CEST
    Poster Gallery Viewing
  • 10:00 – 19:00 CEST
    Sponsor Solutions - Visit Sponsor Booths
  • 10:30 – 11:00 CEST
    Making the Risk Management File work for to you to support safety and efficacy of devices.
  • 11:00 – 11:15 CEST
    Meet The Speaker - MDR Technical Overview
  • 11:00 – 11:15 CEST
    Meet The Speaker - Pandemic Readiness
  • 11:00 – 11:15 CEST
    Meet The Speaker - Pressure Cooker
  • 11:00 – 11:15 CEST
    Meet The Speaker - Risk Management
  • 11:15 – 12:00 CEST
    Visit Sponsors - Brain Break
  • 12:00 – 13:00 CEST
    Data Security and Digital Health
  • 12:00 – 13:00 CEST
    Innovative Regulatory Decision Making - Optimised Development Strategies
  • 12:00 – 13:00 CEST
    IVDR Implementation Best Practices and Challenges
  • 12:00 – 13:00 CEST
    MDR Technical Documentation – How to approach important requirements today and in future
  • 13:00 – 13:15 CEST
    Meet The Speaker - Data Security and Digital Health
  • 13:00 – 13:15 CEST
    Meet The Speaker - Implementation Best Practices & Challenges
  • 13:00 – 13:15 CEST
    Meet The Speaker - Innovative Regulatory Decision Making
  • 13:00 – 13:15 CEST
    Meet The Speaker - Technical Documentation
  • 13:15 – 14:00 CEST
    Lunch Break - Visit Sponsors - Brain Break
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Germany Chapter
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Netherlands Chapter
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Switzerland Chapter
  • 13:30 – 14:00 CEST
    Meet the Authors - Software as a Medical Device
  • 14:00 – 14:45 CEST
    All Paths Begin with Clinical Evidence, But Where Can I Go?
  • 14:00 – 14:45 CEST
    Boosting IVDR Transition with Workforce of IVD-industry Experienced Partners
  • 14:00 – 14:45 CEST
    Transforming Regulatory Affairs
  • 15:00 – 16:00 CEST
    Digitalisation in Health Care / (Real World) Evidence & Innovative Technologies
  • 15:00 – 16:00 CEST
    Recognition of CE Marking Outside EU During Transition Period
  • 15:00 – 16:00 CEST
    Risk Management
  • 15:00 – 16:00 CEST
    Software as a Medical Device, Mobile apps, Wearables
  • 16:00 – 16:15 CEST
    Meet The Speaker - Digitalisation in Health Care
  • 16:00 – 16:15 CEST
    Meet The Speaker - Recognition of CE Marking Outside EU During Transition Period
  • 16:00 – 16:15 CEST
    Meet The Speaker - Risk Management
  • 16:00 – 16:15 CEST
    Meet The Speaker - Software as a Medical Device, Mobile Apps, Wearables
  • 16:15 – 16:30 CEST
    Brain Break - Visit Sponsor Booths
  • 16:30 – 17:30 CEST
    Patient Engagement Focused Drug Development
  • 16:30 – 17:30 CEST
    Postmarketing Clinical Follow-up (PMCF)
  • 16:30 – 17:30 CEST
    Reflection on Pandemic
  • 16:30 – 17:30 CEST
    Turbulent Times in Europe: Why the US is taking over the lead in Medical Technology Innovation
  • 17:30 – 17:45 CEST
    Meet The Speaker - Patient Engagement Focused Drug Development
  • 17:30 – 17:45 CEST
    Meet The Speaker - Postmarketing Clinical Follow-up (PMCF)
  • 17:30 – 17:45 CEST
    Meet The Speaker - Reflection on Pandemic
  • 17:30 – 17:45 CEST
    Meet The Speaker - Software-related Medical Technology
  • 18:00 – 19:00 CEST
    Poster Session: IVDR & Medical Devices
  • 18:00 – 19:00 CEST
    Poster Session: Pharmaceuticals
  • Wednesday, May 12, 2021
  • 10:00 – 11:00 CEST
    Article 117
  • 10:00 – 11:00 CEST
    EU MDR Clinical Investigations
  • 10:00 – 11:00 CEST
    Reference Labs
  • 10:00 – 11:00 CEST
    The Regulatory & Standards Landscape for AI
  • 10:00 – 17:00 CEST
    Poster Gallery Viewing
  • 10:00 – 19:00 CEST
    Sponsor Solutions - Visit Sponsor Booths
  • 11:00 – 11:15 CEST
    Meet The Speaker - Article 117
  • 11:00 – 11:15 CEST
    Meet The Speaker - EU MDR Clinical Investigations
  • 11:00 – 11:15 CEST
    Meet The Speaker - Reference labs
  • 11:00 – 11:15 CEST
    Meet The Speaker - The Regulatory & Standards Landscape for AI
  • 11:15 – 12:00 CEST
    Visit Sponsors - Brain Break
  • 12:00 – 12:30 CEST
    Aesthetic devices under MDR: Emerging Challenges for Aesthetic Manufacturers: What is the State of the Art?
  • 12:00 – 13:00 CEST
    ATMPs/Cell and Gene Therapies: Regulatory Affairs in Academia and the Future of CAR T Cell Therapies
  • 12:00 – 13:00 CEST
    Economic Operators
  • 12:00 – 13:00 CEST
    Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?
  • 12:30 – 13:00 CEST
    Industry Advocacy; the Power of Collective Voice
  • 13:00 – 13:15 CEST
    Meet The Speaker - Aesthetic Devices Under MDR & Industry Advocacy; the Power of Collective Voice Industry advocacy; the power of Collective Voice
  • 13:00 – 13:15 CEST
    Meet The Speaker - ATMPs/Cell and Gene Therapies
  • 13:00 – 13:15 CEST
    Meet The Speaker - Economic Operators
  • 13:00 – 13:15 CEST
    Meet The Speaker - Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?
  • 13:15 – 14:00 CEST
    Lunch Break - Visit Sponsors - Brain Break
  • 13:40 – 14:00 CEST
    Roundtable Discussion: Find the Elusive PMCF Data: The Needle in the Haystack
  • 13:40 – 14:00 CEST
    Roundtable Discussion: Meeting FDA : Do's and Don'ts
  • 13:40 – 14:00 CEST
    Roundtable Discussion: RegOps - Integrate Compliancy to Medical Software Development
  • 13:40 – 14:00 CEST
    Roundtable Discussion: Using a Global Regulatory Intelligence Database for Better Decision-Making
  • 14:00 – 14:45 CEST
    Global Digital Transformation for MedTech Regulatory Affairs
  • 14:00 – 14:45 CEST
    Maintaining Regulatory Compliance in an Age of Continual Change and Digitalization
  • 14:00 – 14:45 CEST
    The Leading Global Solution for All Your Proofreading Tasks
  • 15:00 – 15:30 CEST
    Labelling: Robust Labeling Systems – key to avoiding inspection findings, recalls and the cost of reworking batches
  • 15:00 – 16:00 CEST
    IVDR Regulatory Strategy: How to Comply to IVDR; for Manufacturers and Health institutions with LDTs
  • 15:00 – 16:00 CEST
    Other Regions
  • 15:00 – 16:00 CEST
    Post Market Surveillance under the MDR
  • 15:30 – 16:00 CEST
    Labelling: Private Label Drugs Challenges to Meet the Regulatory Requirements
  • 16:00 – 16:15 CEST
    Meet The Speaker - Labelling
  • 16:00 – 16:15 CEST
    Meet The Speaker - LDT's
  • 16:00 – 16:15 CEST
    Meet The Speaker - Other Regions
  • 16:00 – 16:15 CEST
    Meet The Speaker - Postmarketing Surveillance
  • 16:15 – 17:00 CEST
    Visit Sponsors - Brain Break
  • 17:00 – 18:00 CEST
    Biologics and Biosimilars
  • 17:00 – 18:00 CEST
    Companion Diagnostics: The Path for Companion Diagnostics Under IVDR
  • 17:00 – 18:30 CEST
    Clinical Evaluation Debate
  • 17:00 – 18:30 CEST
    Medical Device Quality Management Systems (e.g., ISO 13485)
  • 18:00 – 18:15 CEST
    Meet The Speaker - Biologics and Biosimilars
  • 18:00 – 18:15 CEST
    Meet The Speaker - Companion Diagnostics
  • 18:15 – 19:15 CEST
    Combination Products
  • 18:30 – 18:45 CEST
    Meet The Speaker - Clinical Evaluation Debate
  • 18:30 – 18:45 CEST
    Meet The Speaker - Medical Device Quality Management Systems
  • 19:15 – 19:30 CEST
    Meet The Speaker - Combination Products