Skip to main content


Full Schedule

Full Schedule

  • 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