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Full Schedule

Full Schedule

  • Wednesday, May 12, 2021
  • 10:00 – 11:00 CET
    ATMPs/Cell and Gene Therapies: Regulatory Affairs in Academia and the Future of CAR T Cell Therapies
  • 10:00 – 11:00 CET
    EU MDR Clinical Investigations
  • 10:00 – 11:00 CET
    Reference Labs
  • 10:00 – 11:00 CET
    The regulatory & standards landscape for AI
  • 10:00 – 17:00 CET
    Poster Gallery Viewing
  • 11:00 – 11:15 CET
    Meet The Speaker - ATMPs/Cell and Gene Therapies
  • 11:00 – 11:15 CET
    Meet The Speaker - EU MDR Clinical Investigations
  • 11:00 – 11:15 CET
    Meet The Speaker - Reference labs
  • 11:00 – 11:15 CET
    Meet The Speaker - The regulatory & standards landscape for AI
  • 11:15 – 12:00 CET
    Visit Sponsors - Brain Break
  • 12:00 – 12:30 CET
    Aesthetic devices under MDR: Emerging Challenges for Aesthetic Manufacturers: What is the State of the Art?
  • 12:00 – 13:00 CET
    Biologics and Biosimilars
  • 12:00 – 13:00 CET
    Economic Operators
  • 12:00 – 13:00 CET
    Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; are you ready?
  • 12:30 – 13:00 CET
    Industry advocacy; the power of Collective Voice
  • 13:00 – 13:15 CET
    Meet The Speaker - Aesthetic devices under MDR & Industry advocacy; the power of Collective Voice
  • 13:00 – 13:15 CET
    Meet The Speaker - Biologics and Biosimilars
  • 13:00 – 13:15 CET
    Meet The Speaker - Economic Operators
  • 13:00 – 13:15 CET
    Meet The Speaker - Market Surveillance v. Post Market surveillance
  • 13:15 – 14:00 CET
    Lunch Break - Visit Sponsors - Brain Break
  • 14:00 – 14:45 CET
    Sponsored Sessions
  • 15:00 – 16:00 CET
    Labelling
  • 15:00 – 16:00 CET
    LDT's: IVDR Regulatory Strategy: How to comply to IVDR; for Manufacturers and Health institutions with LDTs
  • 15:00 – 16:00 CET
    Other Regions
  • 15:00 – 16:00 CET
    Post Market Surveillance under the MDR
  • 16:00 – 16:15 CET
    Meet The Speaker - Labelling
  • 16:00 – 16:15 CET
    Meet The Speaker - LDT's
  • 16:00 – 16:15 CET
    Meet The Speaker - Other Regions
  • 16:00 – 16:15 CET
    Meet The Speaker - Postmarketing Surveillance
  • 16:15 – 17:00 CET
    Visit Expo - Brain Break
  • 17:00 – 18:00 CET
    Combination Products
  • 17:00 – 18:00 CET
    Companion Diagnostics: The Path for Companion Diagnostics Under IVDR
  • 17:00 – 18:30 CET
    Clinical Evaluation Debate
  • 17:00 – 18:30 CET
    Medical Device Quality Management Systems (e.g., ISO 13485)
  • 18:00 – 18:15 CET
    Meet The Speaker - Companion Diagnostics
  • 18:00 – 19:00 CET
    Article 117
  • 18:30 – 18:45 CET
    Meet The Speaker - Clinical Evaluation Debate
  • 18:30 – 18:45 CET
    Meet The Speaker - Medical Device Quality Management Systems
  • 19:00 – 19:15 CET
    Meet The Speaker - Combination products and Article 117