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Browse sessions by each day. Click on a session to view if additional purchase may be required, presentation details and more. Presentation slide decks may not be available for all sessions.

Full Schedule

Full Schedule

  • Tuesday, May 10, 2022
  • 08:00 – 18:00 CEST
    Registration Open
  • 09:00 – 16:00 CEST
    Building a Sustainable Regulatory Strategy in a Challenging Environment
  • 09:00 – 16:00 CEST
    Implementing PMCF for Medical Devices
  • 09:00 – 16:00 CEST
    IVDR Implementation Today: Learn From Early Adaptors
  • 09:00 – 16:00 CEST
    Regulatory Leadership
  • 16:30 – 18:30 CEST
    Opening Plenary Session: The Promise and Possibility of Smart Device and Drug Data Repositories to Improve Patient Outcomes
  • 18:30 – 20:00 CEST
    Opening Reception
  • Wednesday, May 11, 2022
  • 07:30 – 18:00 CEST
    Registration Open
  • 08:30 – 09:00 CEST
    SSCP: A Practical Approach and Lessons Learnt so far
  • 08:30 – 09:30 CEST
    ATMPs/Cell and Gene Therapies
  • 08:30 – 09:30 CEST
    IVD Roll Out 2022
  • 08:30 – 10:45 CEST
    Artificial Intelligence
  • 08:30 – 17:45 CEST
    Poster Viewing & Voting
  • 09:00 – 09:30 CEST
    Straight-Forward Strategies for Meeting Usability Requirements for MDR
  • 09:45 – 10:15 CEST
    Biosimilars
  • 09:45 – 10:45 CEST
    Important Concepts of Equivalence
  • 09:45 – 10:45 CEST
    Regulation Changes: EU IVDR
  • 10:15 – 10:45 CEST
    Pediatrics and Orphan Regulations
  • 10:45 – 11:15 CEST
    Chapter/LNG Meet and Greets
  • 10:45 – 11:15 CEST
    Presenters at Posters
  • 10:45 – 11:15 CEST
    Refreshment Break in Exhibit Area
  • 11:15 – 12:15 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 11:15 – 12:15 CEST
    Life Cycle Management
  • 11:15 – 12:15 CEST
    Quality Management System
  • 11:15 – 12:15 CEST
    Regulation Changes: EU IVDR
  • 12:15 – 13:30 CEST
    Lunch, Exhibits, Posters
  • 13:00 – 13:30 CEST
    Beyond Compliance: Connecting Quality and Regulatory to Gain Operational Excellence
  • 13:00 – 13:30 CEST
    Practical approach to vigilance reporting in EU
  • 13:00 – 13:30 CEST
    The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success
  • 13:00 – 13:30 CEST
    UK market access: UKCA challenges in uncertain times
  • 13:30 – 14:30 CEST
    Companion Diagnostics
  • 13:30 – 14:30 CEST
    Effectively Managing Clinical Data Collection Using Cost Sensitive Methods
  • 13:30 – 14:30 CEST
    Global facilitated regulatory pathways for COVID-19
  • 13:30 – 14:30 CEST
    Orthopedic - A Notified Body Perspective on the Impact of the Regulation EU 2017/745 on Orthopedic and Orthopedic Trauma Implants
  • 14:45 – 15:15 CEST
    Current and Future Regulations for Medical Devices and IVD in Switzerland and the Relationsship to EU Regulations
  • 14:45 – 15:45 CEST
    Innovative Technologies
  • 14:45 – 15:45 CEST
    Performance Studies
  • 14:45 – 15:45 CEST
    Regulatory Business - Organizational Techniques
  • 14:45 – 15:45 CEST
    Regulatory Requirements for Medical Devices Within the UK
  • 15:45 – 16:15 CEST
    Presenters at Posters
  • 15:45 – 16:15 CEST
    Refreshment Break in Exhibit Area
  • 16:15 – 17:15 CEST
    Implementation of the new Clinical Trials Regulation
  • 16:15 – 17:45 CEST
    Assessment of Clinical Processes as Part of a Quality System
  • 16:15 – 17:45 CEST
    Cybersecurity
  • 16:15 – 17:45 CEST
    High Risk IVDs - Conformity Assessment of Class D Devices in the Absence of the Needed Regulatory Infrastructure
  • 17:15 – 17:45 CEST
    ATMPs/Cell and Gene Therapies: Is the Covid-19 Pandemic a Game Changer in GMO Regulation?
  • 18:30 – 20:30 CEST
    Networking Party – Heineken Experience (SOLD OUT)
  • Thursday, May 12, 2022
  • 07:30 – 16:30 CEST
    Registration Open
  • 08:30 – 09:30 CEST
    Combination Products
  • 08:30 – 09:30 CEST
    More than EU
  • 08:30 – 09:30 CEST
    Regulatory Strategy/Global Regulatory Planning - Step Inside the Real World Real-world Evidence Strategies in FDA Device Applications 2022
  • 08:30 – 09:30 CEST
    The New UK Medical Device Regulation for IVDs
  • 08:30 – 16:00 CEST
    Poster Viewing
  • 09:45 – 10:45 CEST
    e-Regulatory
  • 09:45 – 10:45 CEST
    Low Risk Devices
  • 09:45 – 10:45 CEST
    Regulation Changes - Strategies for Meaningful Interactions With Authorities/NBs
  • 09:45 – 10:45 CEST
    Rollout IVDR 2022: Performance Evaluation of IVD Medical Devices and the role of PMPF studies; how much evidence do you really need to get compliant with the IVDR?
  • 10:45 – 11:15 CEST
    Chapter/LNG Meet and Greets
  • 10:45 – 11:15 CEST
    Presenters at Posters
  • 10:45 – 11:15 CEST
    Refreshment Break in Exhibit Area
  • 11:15 – 12:15 CEST
    EUDAMED & UDI – Are you ready?
  • 11:15 – 12:15 CEST
    Regulatory Business - Regulatory Planning
  • 11:15 – 12:15 CEST
    Regulatory Strategy
  • 11:15 – 12:15 CEST
    Risk Management
  • 12:15 – 13:30 CEST
    Lunch, Exhibits, Posters
  • 13:00 – 13:30 CEST
    Getting your regulatory ducks in a row - Why a regulatory information strategy is critical for successful MDR/IVDR transitions
  • 13:00 – 13:30 CEST
    Major Pain Points and Solutions for Medical Device Manufacturers for EU MDR 2017/74 Compliance
  • 13:00 – 13:30 CEST
    Technology-Enabled Clinical Trials - Current and Future Trends
  • 13:00 – 13:30 CEST
    The impact of Digitalization and Automation on Clinical Evaluation Reports.
  • 13:30 – 14:30 CEST
    Global Regulatory Outlook: How will the landscape evolve and how should regulatory professions prepare?
  • 13:30 – 14:30 CEST
    Postmarketing Surveillance
  • 13:30 – 14:30 CEST
    Regulatory for Clinical
  • 13:30 – 14:30 CEST
    Views from early adaptors on reaching IVDR compliance for CE-IVDs and in-house devices
  • 14:30 – 15:00 CEST
    Presenters at Posters
  • 14:30 – 15:00 CEST
    Refreshment Break in Exhibit Area
  • 15:00 – 16:00 CEST
    Drug-Device Combination Products Under MDR
  • 15:00 – 16:00 CEST
    How to handle the challenges from MDR’s Article 120?
  • 15:00 – 16:00 CEST
    Regulatory Business - Navigating the Regulatory Risk of Your Third-Party Medical Device & IVD Distributors
  • 15:00 – 16:00 CEST
    Use of Standards to Demonstrate State-of-Art
  • 16:00 – 16:30 CEST
    Closing Remarks & Farewell Toast