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Clinical Trial Events

13th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2025

Jan 28–29

Jan 28–29, 2025 Ended

Holiday Inn Munich City Centre · Munich, Germany · In person

Hear fresh insight on regulatory changes and hottest technologies impacting European MedTech trials. The event will provide insights into regulatory updates, trial-running techniques for small companies, and the latest innovations in the medical device and diagnostics community. It is a 2-day event for networking with industry peers, trial sponsors, manufacturers, and vendors, and tackle post-MDR challenges. Attendees will learn about industry trends and outsourcing challenges. This is a key opportunity to succeed in a challenging industry.

Venue
Holiday Inn Munich City Centre
Program
36 sessions
33 speakers

Agenda

Times in Munich (CET)
Tue, Jan 28 Wed, Jan 29

  1. 8:15 AM

    Networking

    Registration and refreshments

  2. 8:50 AM

    10 min

    Other

    Chairperson’s opening remarks

    Stephen Gilbert, Else Kröner Fresenius Center for Digital Health

  3. 9:00 AM

    30 min

    Talk

    The impact of the EU’s AI Act on the medical device sector

    Stephen Gilbert, Else Kröner Fresenius Center for Digital Health

  4. 9:30 AM

    30 min

    Talk

    Streamlining success: navigating preclinical to pre-market pathways for study approval

    Enrico Perfler, 1MED

  5. 10:00 AM

    30 min

    Talk

    AI and software-as-a-medical product development and commercialization: challenges and new developments

    Carmen Bellebna, deepeye Medical

  6. 10:30 AM

    30 min

    Talk

    Building a strong foundation: robust, scalable, clinical trials platform for Medtech

    Anthony Arena, Medidata

  7. 11:00 AM

    30 min

    Break

    Morning refreshments and networking

  8. 11:30 AM

    30 min

    Talk

    Exploring the future of medical device and drug combination products: insights from EMA and key considerations for MR and MDR compliance

    Miguel Hernandez, UCB

  9. 12:00 PM

    30 min

    Talk

    2025 MedTech industry benchmark report

    Páll Jóhannesson, Greenlight Guru

  10. 12:30 PM

    30 min

    Talk

    Navigating clinical data requirements for CE mark certification

    Anna Mayer, TÜV SÜD

  11. 1:00 PM

    60 min

    Break

    Lunch and networking

  12. 2:00 PM

    30 min

    Talk

    Commercialization of innovations and scaling up with the right business model

    Alexander Stanke, Preventicus

  13. 2:30 PM

    30 min

    Talk

    Practical considerations for conducting a clinical investigation

    Frank Maier, RQM+

  14. 3:00 PM

    30 min

    Talk

    Innovation trends, drivers and detractors in healthcare for the next decade

    Pradipto Kolay, Philips

  15. 3:30 PM

    30 min

    Break

    Afternoon refreshments and networking

  16. 4:00 PM

    30 min

    Talk

    Addressing the investment gap in medical devices: challenges and opportunities

    Max G. Ostermeier, Implandata Ophthalmic Products

  17. 4:30 PM

    30 min

    Talk

    Medical device development roadmap: strategic decision-making on the path to market

    Frank Keulen, Premier Research Michael Edwards, Premier Research

  18. 5:00 PM

    45 min

    Panel

    Streamlining compliance: agile certification for AI medical devices in the European market

    Alexander von Janowski, TÜV AI.Lab Danish Mairaj, Resyca Pradipto Kolay, Philips Piet Smet, QBD Group

  19. 5:45 PM

    Other

    Chairperson’s closing remarks

    Stephen Gilbert, Else Kröner Fresenius Center for Digital Health

  1. 8:15 AM

    Networking

    Registration and refreshments

  2. 8:45 AM

    15 min

    Other

    Chairperson’s opening remarks

    Pavel Kusnierik, Contipro

  3. 9:00 AM

    30 min

    Panel

    Enhancing collaboration and efficiency: the evolving relationship between CROs and medical device manufacturers

    Methee Schreuder, Xeltis Mark Cregan, Medaxis Luca Franceschini, Aboca Pavel Kusnierik, Contipro

  4. 9:30 AM

    30 min

    Talk

    Key partnerships for your clinical trial: What are the most important considerations?

    Mark Cregan, Medaxis

  5. 10:00 AM

    30 min

    Talk

    Challenges in conducting medical device trials in Europe and the UK

    Stacy Gardner, MCRA – an IQVIA business

  6. 10:30 AM

    30 min

    Talk

    Bouncing back on the path through NB’s question rounds – challenges and lessons learned during certification of clinical evaluation (class IIb and III)

    Renate Cizkova, ELLA-CS

  7. 11:00 AM

    30 min

    Break

    Morning refreshments and networking

  8. 11:30 AM

    30 min

    Talk

    Integrating medical device cybersecurity: shaping the landscape of 2025

    David Bicknell, GlobalData

  9. 12:00 PM

    30 min

    Talk

    How small to medium-sized companies can accelerate innovation and improve compliance through data-driven decision making

    Adnan Shah, Deloitte Heike Fischer, Deloitte

  10. 12:30 PM

    30 min

    Talk

    Exploring how digital platforms and telemonitoring are shaping clinical thinking and decision making

    Roxana Mittler-Matica, DRK-Schmerz-Zentrum Mainz Alice Hospital Ingo Horak, Luscii

  11. 1:00 PM

    60 min

    Break

    Lunch and networking

  12. 2:00 PM

    30 min

    Talk

    Using AI to enhance clinical trial design and efficiency

    Danish Mairaj, Resyca

  13. 2:30 PM

    15 min

    Talk

    From concept to market – hurdles for AI-driven medical devices

    Andreas Beust, GCP-Service

  14. 2:45 PM

    15 min

    Talk

    From burden to breakthrough: next-gen CRO & Milo’s AI slash data entry, errors, and cost with no EHR integration required

    Chems Hachani, Eclevar Medtech Nikhil A. Khadabadi, Eclevar

  15. 3:00 PM

    30 min

    Talk

    Propelling healthcare innovation: the crucial role of real-world data for medical device companies

    Herbert Mauch, Cochlear AG

  16. 3:30 PM

    30 min

    Break

    Afternoon refreshments and networking

  17. 4:00 PM

    60 min

    Roundtable

    Problem-Solving Roundtable Discussions

    Karel Volenec, ELLA-CS Herbert Mauch, Cochlear AG Yvonne Hoogeveen, Wellinq Pavel Kusnierik, Contipro

Speakers