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Full Schedule

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Full Schedule

  • Tuesday, May 7, 2024
  • 07:30 – 18:00 CEST
    Registration Hours
  • 07:30 – 18:00 CEST
    Speaker Ready Room Open (B04)
  • 08:30 – 09:30 CEST
    Biocompatibility: ‘Substances of concern’ – Have you checked? GSPR 10.4 a practical guide
  • 08:30 – 09:30 CEST
    Development and Registration of Therapeutic Radiopharmaceuticals in the EU - Navigating Opportunities and Challenges
  • 08:30 – 09:30 CEST
    Kick-off MDR panel
  • 08:30 – 09:30 CEST
    Patient Access
  • 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?
  • 09:45 – 16:45 CEST
    Exhibition Open
  • 09:50 – 10:50 CEST
    Artificial Intelligence in the context of the IVDR – How to keep the revolution under control.
  • 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
    Presenters at Posters (C Level)
  • 10:50 – 11:30 CEST
    Refreshment Break in Exhibit Area on all Levels
  • 11:30 – 12:00 CEST
    Global IVDs
  • 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 and The AI Act: A Match Made in Heaven or The Odd Couple?
  • 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
    SESSION IS FULL: Solutions Circle: RA-GPT – The Future of the Regulatory Profession
  • 12:30 – 13:00 CEST
    Solution Circle: The Time is Now: The Journey to Becoming RCC Certified!
  • 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
    Chapter/Local Networking Group Meet and Greets
  • 12:30 – 13:45 CEST
    Networking Lunch in Exhibit Hall on all Levels
  • 13:00 – 13:30 CEST
    Sponsored Presentation: 3 Changes Affecting MedTech Regulatory Teams
  • 13:00 – 13:30 CEST
    Sponsored Presentation: How to accelerate global market entry and to reduce time-to-market? A Notified/Certification body perspective
  • 13:00 – 13:30 CEST
    Sponsored Presentation: Objective-driven systems: How to build effective and continuous Regulatory Intelligence and Clinical Surveillance
  • 13:00 – 13:30 CEST
    Sponsored Presentations Purdie Pascoe: PMCF Surveys: from plan to action
  • 13:00 – 13:30 CEST
    Sponsored Presentations QbD Group: Transitional provisions of the IVDR - Can I sit back and relax?
  • 13:00 – 13:30 CEST
    Sponsored Presentations RIMSYS: Clearing up EUDAMED confusion for medtech regulatory teams
  • 13:15 – 13:45 CEST
    SESSION IS FULL Repeat: Solutions Circle: RA-GPT – The Future of the Regulatory Profession
  • 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
    The future of standardization in Medtech and its impact on your regulatory 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
    From China to WHO: Strategies and Updates to Accelerate China and 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 on all Levels
  • 16:05 – 16:45 CEST
    Presenters at Posters (C Level)
  • 16:10 – 16:40 CEST
    Sponsored Presentation: How It Works: Your Questions About Notified Bodies & Testing Houses Answered
  • 16:10 – 16:40 CEST
    Sponsored Presentation: Leveraging AI for Successful Clinical Evaluation and PMCF Strategies
  • 16:10 – 16:40 CEST
    Sponsored Presentation: MDR has come: A call for a proactive boost in Medtech Innovation Industry
  • 16:10 – 16:40 CEST
    Sponsored Presentation: Regulatory Intelligence: From information overload to strategic decision-making
  • 16:10 – 16:40 CEST
    Sponsored Presentation: Regulatory Transformation: Leveraging AI & Digital Transformation to Enable Regulatory Excellence
  • 16:10 – 16:40 CEST
    Sponsored Presentation: Using Clock Stops Wisely to Appropriately Address CHMP Issues – Why Time Matters
  • 16:45 – 17:45 CEST
    Don’t get orphaned: how to be novel in the IVDR environment.
  • 16:45 – 17:45 CEST
    EMA Scientific Advice for high-risk devices – What we know so far
  • 16:45 – 17:45 CEST
    Importance of New Active Substance status for biologics, and CMC strategies for development of C&G therapies
  • 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
  • 18:30 – 22:30 CEST
    Networking Dinner (ticket required): Spreespeicher Event (Stralauer Allee 2)