14th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2026

Uniting expertise and innovation to shape the future of medical device and diagnostic trials

27 - 28

January

2026
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary
  • Agenda
  • Advisory Board
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
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Featured Speakers

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Marco Marchetti​

MD. Director HTA Department, Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS), Co-Chair of the EU HTA Member State Coordination Group, (HTACG), European Union

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Dr. Fatima Bennai-Sanfourche​

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

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Dr. Manuela Stauss-Grabo​

Senior Vice President and Head of Clinical Research, Fresenius Medical Care

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    2026 Sponsors Include:

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    Company Information

    1MED, is the leading European MedTech specialized solutions provider,
    offering end-to-end development expertise within the medical device, novel technology and combination products fields.

    Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED’s mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

    Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support, digital solutions and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices within the last 5 years.

    Company Website

    To learn more, please visit our website - https://www.1med.ch/

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    Company Information

    The Leading Toolbox for MedTech Clinical Data Collection
    Greenlight Guru Clinical (formerly SMART-TRIAL) is a single, compliant platform for collection and management of all clinical evidence, safety, and performance data.

    Company Website

    To learn more, please visit our website - https://www.greenlight.guru/clinical-electronic-data-capture-software

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    Company Information

    RQM+ is the world’s leading MedTech service provider offering consulting, clinical trial, lab and reimbursement services plus technology solutions to support the entire product lifecycle. With many former FDA, Medicines, MHRA and notified body regulators, the RQM+ team has deep expertise in all clinical specialties.

    Company Website

    To learn more, please visit our website - https://www.rqmplus.com/

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    Company Information

    GCP-Service International is a small-to-mid-sized, full-service CRO with headquarter in Bremen, Germany, conducting clinical investigations with medical devices and in-vitro diagnostic devices nationally and internationally for almost 20 years. We focus on using technology and flexible processes to deliver high quality, customized trial solutions for our clients.

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    Company Information

    Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

    Company Website

    To learn more, please visit our website - http://www.premier-research.com/

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    Company Information

    Rede Optimus AG is your global Clinical Research Organization to conduct your medical device clinical trial. With an extensive network in the medical device field we form a true partnership with our customers by aligning your needs to ours. We are here to help you from A-Z in your clinical trial.

    Company Website

    To learn more, please visit our website - https://redeoptimus.com/

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    Company Information

    IQVIA MedTech, part of IQVIA, is a global strategic partner for accelerating MedTech innovation. By intelligently connecting the right insights, technology and MedTech expertise, we enable the medical device and in vitro diagnostics industry to enhance healthcare outcomes. Our market leading and specialized solutions and services help boost product strategy with advanced data driven insights, optimize clinical success with accelerated trials and real-world evidence, streamline efficient pathways for regulatory approvals, ensure compliance with comprehensive cloud-based solutions and field recall, and maximize business performance with augmented team solutions along the complete product lifecycle. Learn more at iqviamedtech.com

    Company Website

    To learn more, please visit our website - iqviamedtech.com

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    Company Information

    QbD Clinical is a specialized CRO focused on accelerating the development and market entry of innovative medical devices and IVD in cardiovascular, neurology, orthopedics, and infectious diseases, providing deep MedTech expertise and tailored support to navigate regulatory and development challenges.

    Company Website

    To learn more, please visit our website - https://www.qbdgroup.com/clinical

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    Company Information

    Deloitte is a leading global provider of audit and assurance, consulting, financial advisory, risk advisory, tax and related services. Our global network of member firms and related entities in more than 150 countries and territories (collectively, the “Deloitte organization”) serves four out of five Fortune Global 500® companies. Learn how Deloitte’s approximately 312,000 people make an impact that matters at www.deloitte.com.

    Company Website

    To learn more, please visit our website - www.deloitte.com

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

    To learn more, please visit our website - https://www.medidata.com

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      The meeting place for healthcare pioneers and innovators

      ➠ Meet and hear from key MedTech manufacturers and solution providers in order to streamline your clinical processes and accelerate your overall trial timelines

      ➠ Hear from 15+ clinical operations and regulatory affairs professionals from medical device manufacturers on a range of topics around running a trial effectively, working with CROs and navigating regulations

      120+

      Attendees

      		20+

      Exhibitors

      		15+

      Speakers
      120+

      Attendees

      		20+

      Exhibitors
      15+

      Speakers

      Testimonials

      Agenda

      • 27 Jan 2026
      • 28 Jan 2026
      Expand All

      Streams

      Stream one

      STREAM A: Medical Device Trials & Evidence

      Stream two

      STREAM B: In Vitro Diagnostics Performance & Validation

      11:30 AM

      CASE STUDY Validating digital diagnostics and complying with both IVDR and the AI Act

      • Streamlining evidence generation without duplicating AI and IVDR submissions
      • Understanding notified body expectations for performance claims and bias mitigation
      • Identifying realistic validation methods for early-stage digital diagnostics

      Speakers

      Dr. Philipp Schatz
      Global Regulatory Leader – IVD, Bayer 12:00

      12 PM

      Session reserved for event sponsor

      12:30 PM

      Using PMPF to expand intended purpose and strengthen clinical claims

      • Designing general-purpose PMPF studies to validate new settings, claims, or patient population
      • Addressing gaps from initial submissions and identifying emerging risks
      • Using PMCF outcomes to support intended purpose expansion or claim updates

       

      1 PM

      Lunch and networking

      2 PM

      Navigating the new competent authority application process for companion diagnostics under IVDR

      • Understanding the updated competent authority application pathway for CDx under IVDR
      • Sharing lessons learned from real-world submissions and post-application interactions
      • Identifying best practices for aligning diagnostic and therapeutic regulatory timelines when engaging with authorities

      Speakers

      Dr Sarah Johnson
      VP, Head of Clinical Affairs, QIAGEN

      2:30 PM

      Session reserved for event sponsor

      3 PM

      PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

      • Exploring options when traditional clinical data requirements cannot be fully met at submission
      • Establishing a robust clinical strategy using early dialogue, risk-based justification and post-market commitments
      • Leveraging expert panels, NB consultations and scientific advice to de-risk approval pathways

      Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      Speakers

      Jens Pfannkuche
      Director Regulatory Affairs, Penumbra
      Dr. Manuela Stauss-Grabo
      Senior Vice President and Head of Clinical Research, Fresenius Medical Care
      Dr. Fatima Bennai-Sanfourche
      Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Bridging legacy IVD devices to IVDR clinical expectations

      • Translating past performance data into IVDR-compliant clinical evidence
      • Substantiating full intended purpose claims across settings and populations
      • Avoiding delays by proactively identifying outdated or missing data

       

      Speakers

      Jens Pfannkuche
      Director Regulatory Affairs, Penumbra

      4:30 PM

      Session reserved for event sponsor

      5 PM

      PANEL DISCUSSION Coordination assessment processes for medical devices and IVDs

      • Discussing lessons learned from coordinated assessments for medical devices under Article 78
      • Considering the impact of the European Commission’s pilot project for IVD stakeholders
      • Sharing practical approaches for preparing evidence packages and coordinating with multiple authorities during assessments

      Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      Speakers

      Dr. Fatima Bennai-Sanfourche
      Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer
      Marta Carnielli
      Head Of Certification, TÜV SÜD

      8:15 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Dr. Fatima Bennai-Sanfourche
      Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      9 AM

      Strengthening your trial strategy with HTA-aligned evidence

      • Design trials that support both CE marking and joint clinical assessment
      • Anticipate payer expectations when choosing clinical endpoints
      • Avoid duplicative evidence generation by aligning early

      Speakers

      Marco Marchetti
      MD. Director HTA Department, Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS), Co-Chair of the EU HTA Member State Coordination Group, (HTACG), European Union

      9:30 AM

      Session reserved for event sponsor

      10 AM

      Adapting trial designs to global market realities

      • Align protocol design with MDR, FDA and global regulatory expectations
      • Manage endpoint variability across geographies without undermining quality
      • Avoid costly rework by building flexibility into trial strategy

       

      Speakers

      Dr. Manuela Stauss-Grabo
      Senior Vice President and Head of Clinical Research, Fresenius Medical Care

      10:30 AM

      Session reserved for event sponsor

      11 AM

      Morning refreshments and networking

      11:30 AM

      PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

      • Understand how notified body reviews differ by organization
      • Learn what makes a CER or PMCF study “good enough” in practice
      • Avoid overcommitting with evidence plans that are too ambitious

       

      Speakers

      Richard Holborow
      Global Head Clinical Compliance, BSI
      Dr. Tonia Jeiter
      Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD
      Dr. Ulrich Nitsche
      Global Director Clinical Centre of Excellence, TÜV SÜD

      12 PM

      Session reserved for event sponsor

      12:30 PM

      Choosing the right partner for clinical success

      • Decide between full-service CROs, niche providers and consultants
      • Map your internal capabilities to your outsourcing needs
      • Streamline communication and accountability across vendors

      Speakers

      Autumn Lang, PhD, RAC
      Director Clinical Affairs, deepeye Medical

      1 PM

      Lunch and networking

      2 PM

      Navigating clinical compliance challenges in emerging medical device technologies

      • Spotting compliance risks early for novel or AI-enabled devices
      • Best practices for bridging clinical and regulatory teams
      • Lessons from recent reviews and practical recommendations for sponsors

      Speakers

      Richard Holborow
      Global Head Clinical Compliance, BSI

      2:30 PM

      Session reserved for event sponsor

      3 PM

      Leveraging retrospective data for CE marking and robust clinical evaluation under MDR

      • Sharing a practical case study on using retrospective clinical data to meet evidence requirements for CE marking
      • Demonstrating how to align historical data with current MDR expectations for robust clinical evaluation
      • Highlighting lessons learned, common pitfalls, and tips for ensuring Notified Body acceptance

      Speakers

      Dr Stephan Theinert
      Head Clinical Development, Eyesense

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Simplifying PMCF with realistic and actionable strategies

      • Create lean survey strategies that deliver quality insights
      • Integrate PSURs, CERs and PMCF into a manageable system
      • Reduce documentation burden without losing regulatory value

      Speakers

      Maike Hiller
      Clinical Development Lead, Philips

      4:30 PM

      Session reserved for event sponsor

      5 PM

      Q&A session: lessons learned from former Notified Body expert

      • See how to align robust clinical evidence for MDR from an NB perspective
      • Bridge the gap between reviewer expectations and sponsor realities
      • Optimize clinical trial design and submissions for smoother approval

       

      Speakers

      Dr. Tonia Jeiter
      Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Dr. Fatima Bennai-Sanfourche
      Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      NETWORKING DRINKS

      Registration and refreshments

      8:45 AM

      Chairperson’s opening remarks

      Speakers

      Pavel Kusnierik
      Head, Regulatory Affairs, Contipro

      9 AM

      Aligning clinical trial execution with business objectives

      • Examining the “business behind clinical” and how operations leaders can demonstrate ROI, efficiency, and scalability
      • Meeting regulatory expectations while supporting commercial growth
      • Translating clinical results into business impact: internal KPIs that matter
      • Creating adaptable infrastructure for long-term clinical evidence generation

      Speakers

      Dr. Arne Böhling
      Global Clinical Affairs Director, Mölnlycke Healthcare

      9:30 AM

      Generating the right evidence for AI-driven and predictive devices

      • Design prospective studies to validate clinical performance of AI
      • Clarify intended purpose and risk classification from the outset
      • Meet evolving regulatory expectations for AI-enabled systems

      Speakers

      Karny Ilan
      Co-Founder and CEO, Feminai

      10 AM

      Session reserved for event sponsor

      Speakers

      David Burnham
      Senior Vice President Strategic Alliance Management Syneos Health

      10:30 AM

      PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

      • Balance in-house teams with outsourced or consultant support
      • Define key roles from CER writing to PMCF strategy
      • Develop career pathways for growing clinical talent pools

      Speakers

      Dr Stephan Theinert
      Head Clinical Development, Eyesense
      Karny Ilan
      Co-Founder and CEO, Feminai

      11 AM

      Morning refreshments and networking

      11:30 AM

      Planning evaluations that withstand reclassification and scrutiny

      • Future-proof your CERs against class shifts and MDR updates
      • Address challenges when intended purpose evolves with technology
      • Build defensible clinical arguments for AI-enabled systems

      Speakers

      Jie Jia
      Senior Medical Director, Fresenius Kabi

      12 PM

      Session reserved for event sponsor

      12:30 PM

      Lunch and networking

      1:30 PM

      Enhancing clinical evaluation without overburdening

      • Leveraging pre-existing data to reduce duplication in MDR submissions
      • Avoiding overcommitment and scoping expectations with internal stakeholders
      • Case study: Streamlining CER updates for a legacy cardiovascular product

      TBC - Adelina Chiaravalloti, Director, Regulatory Affairs and Clinical Evaluation, Corcym

      2 PM

      Tech Spotlight Session

      2:15 PM

      Tech Spotlight Session

      2:30 PM

      Modernising global data collection for observational and registry studies

      • Piloting practical tools and workflows for collecting high-quality data across international sites
      • Navigating local requirements and global compliance for multi-country observational programs
      • Integrating imaging, monitoring, and electronic trial master files to strengthen data integrity and site collaboration

      Speakers

      Katrin Simioni
      Deputy Head Clinical Operations, AO Foundation

      3 PM

      Afternoon refreshments and networking and Prize Draw

      3:30 PM

      ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry.

      RT1 Proactive management of safety risks in clinical research
      Talia Milosevic, Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences

      RT2 Structuring your clinical team for efficiency and growth
      Dr Stephan Theinert, Head Clinical Development, Eyesense

      RT3 Strengthening clinical data reliability and assurance in device development
      Anna Mayer, Clinical Auditor, TÜV SÜD

      RT4 Fostering positive CRO relationships: tips and best practice
      Luca Franceschini, Clinical Project Manager, Aboca

      Speakers

      Dr Talia Milosevic
      Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
      Dr Stephan Theinert
      Head Clinical Development, Eyesense
      Anna Mayer
      Clinical Auditor, TÜV SÜD
      Luca Franceschini
      Clinical Project Manager, Aboca

      End of conference

      Speakers

      Select a speaker to learn more

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      Marco Marchetti
      MD. Director HTA Department, Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS), Co-Chair of the EU HTA Member State Coordination Group, (HTACG), European Union

      Session Details:

      Strengthening your trial strategy with HTA-aligned evidence

      2026-01-27, 9:00 AM

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      Dr. Fatima Bennai-Sanfourche
      Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

      Session Details:

      PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

      2026-01-27, 3:00 PM

      Session Details:

      Chairperson’s opening remarks

      2026-01-27, 8:50 AM

      Session Details:

      Chairperson’s closing remarks

      2026-01-27, 5:30 PM

      Session Details:

      PANEL DISCUSSION Coordination assessment processes for medical devices and IVDs

      2026-01-27, 5:00 PM

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      Dr. Arne Böhling
      Global Clinical Affairs Director, Mölnlycke Healthcare

      Dr. Arne Böhling is a senior clinical research leader with over one and half decade of experience in the healthcare and medical device industries. Currently Global Clinical Affairs Director at Mölnlycke Health Care, he has previously held leadership roles at Essity and proderm, where he directed global clinical research programs and contributed to the commercial success of innovative healthcare solutions. Dr. Böhling has extensive experience managing cross-functional teams, integrating clinical evidence into product development and market strategies, and aligning research with business objectives. He has served as chairman of a human subject research board and is a frequent speaker at international conferences, sharing insights on clinical study design, dermatological research, and the intersection of science and business in healthcare innovation.

      Session Details:

      Aligning clinical trial execution with business objectives

      2026-01-28, 9:00 AM

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      Dr. Manuela Stauss-Grabo
      Senior Vice President and Head of Clinical Research, Fresenius Medical Care

      Session Details:

      Adapting trial designs to global market realities

      2026-01-27, 10:00 AM

      Session Details:

      PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

      2026-01-27, 3:00 PM

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      Richard Holborow
      Global Head Clinical Compliance, BSI

      Richard Holborow BSc (Hons) MSCST RCCP

      Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

      Session Details:

      PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

      2026-01-27, 11:30 AM

      Session Details:

      Navigating clinical compliance challenges in emerging medical device technologies

      2026-01-27, 2:00 PM

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      Dr. Tonia Jeiter
      Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD

      Session Details:

      PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

      2026-01-27, 11:30 AM

      Session Details:

      Q&A session: lessons learned from former Notified Body expert

      2026-01-27, 5:00 PM

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      Dr. Ulrich Nitsche
      Global Director Clinical Centre of Excellence, TÜV SÜD

      Dr. Ulrich Nitsche, M.D./Ph.D., is Global Director and Head of the Clinical Centre of Excellence at the notified bodies TÜV SÜD NB0123 and TÜV SÜD NB2443. In addition to his work as an internal clinician, Ulrich Nitsche is member of the German Institute for Standardisation (DIN-Normenausschuss) in the Clinical Trials / Clinical Evaluation Working Group. In addition, he is member of the Ethics Committee of the Technical University of Munich and of the Specialised Ethics Committee for Special Procedures of the BfArM. Ulrich Nitsche is a specialist in visceral surgery and a senior emergency physician.

      Session Details:

      PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

      2026-01-27, 11:30 AM

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      Karny Ilan
      Co-Founder and CEO, Feminai

      Session Details:

      Generating the right evidence for AI-driven and predictive devices

      2026-01-28, 9:30 AM

      Session Details:

      PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

      2026-01-28, 10:30 AM

      View In Agenda
      Next speaker
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      Jens Pfannkuche
      Director Regulatory Affairs, Penumbra

      Session Details:

      PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

      2026-01-27, 3:00 PM

      Session Details:

      Bridging legacy IVD devices to IVDR clinical expectations

      2026-01-27, 4:00 PM

      View In Agenda
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      Autumn Lang, PhD, RAC
      Director Clinical Affairs, deepeye Medical

      I have spent over 25 years in the medical device industry focusing on two core challenges: identifying the essential clinical evidence needed for an innovative device and strategizing the most efficient way to acquire it. My work is driven by the conviction that innovation thrives when we eliminate excess overhead and are willing to cross geographic borders to get the evidence we need.

      Session Details:

      Choosing the right partner for clinical success

      2026-01-27, 12:30 PM

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      Maike Hiller
      Clinical Development Lead, Philips

      Session Details:

      Simplifying PMCF with realistic and actionable strategies

      2026-01-27, 4:00 PM

      View In Agenda
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      Katrin Simioni
      Deputy Head Clinical Operations, AO Foundation

      Session Details:

      Modernising global data collection for observational and registry studies

      2026-01-28, 2:30 PM

      View In Agenda
      Next speaker
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      Dr Stephan Theinert
      Head Clinical Development, Eyesense

      Session Details:

      Leveraging retrospective data for CE marking and robust clinical evaluation under MDR

      2026-01-27, 3:00 PM

      Session Details:

      ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2026-01-28, 3:30 PM

      Session Details:

      PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

      2026-01-28, 10:30 AM

      View In Agenda
      Next speaker
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      Dr Talia Milosevic
      Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences

      Talia Milosevic is a Director, Clinical Safety at the Surgical division of Edwards Lifesciences, global company,  focused on developing solutions for patients suffering from structural heart disease.

      With more than 18 years of experience in patient safety and clinical research, Talia has a proven track record in safety risk management, cross-functional safety governance, and implementing safety strategies in complex environment of global medical device studies under various regulatory requirements.

      Talia is passionate about advancing innovative therapies while ensuring the highest standards of patient safety.

      Session Details:

      ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2026-01-28, 3:30 PM

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      Dr Sarah Johnson
      VP, Head of Clinical Affairs, QIAGEN

      Sarah Johnson, PhD, VP, Head of Clinical Affairs for QIAGEN, leads a team of clinical specialists to deliver global multi-site clinical studies on MDx and CDx products.  As an expert in clinical affairs, diagnostics and women’s health, she has >40 peer reviewed publications in the diagnostics field.  Previously she has headed up regulatory affairs, medical affairs and research in other diagnostic companies, and has been a UK company director.  She has a PhD in cell biology and was a qualified medical geneticist.

      Session Details:

      Navigating the new competent authority application process for companion diagnostics under IVDR

      2026-01-27, 2:00 PM

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      Anna Mayer
      Clinical Auditor, TÜV SÜD

      Anna has more than 5 years experience in Clinical Investigations with Medical Device and over 8 years with Notified Body Certification of Medical Device Manufacturer.

      Session Details:

      ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2026-01-28, 3:30 PM

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      Dr. Philipp Schatz
      Global Regulatory Leader – IVD, Bayer 12:00

      Session Details:

      CASE STUDY Validating digital diagnostics and complying with both IVDR and the AI Act

      2026-01-27, 11:30 AM

      View In Agenda
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      Luca Franceschini
      Clinical Project Manager, Aboca

      Session Details:

      ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2026-01-28, 3:30 PM

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      Marta Carnielli
      Head Of Certification, TÜV SÜD

      With 30 years of experience in the field of IVD medical devices, Marta Carnielli currently serves as the Head of Certification IVD at TÜV SÜD Product Service GmbH, where she oversees the certification process for IVD medical devices. She ensures accreditations, designations and authorizations relevant to IVDs are maintained by TÜV SÜD.

      Marta represents TÜV SÜD in regulatory committees and conferences, supporting management and technical experts in interpretation of regulatory requirements. She chairs the IVD Notified Bodies (NB) Working Group within the NB Coordination Group, NBCG-MED.

      Before joining TÜV SÜD, Marta held various roles of increasing responsibility at Ortho Clinical Diagnostics within the Customer Technical Support and the Quality, Regulatory and Compliance department.

      Session Details:

      PANEL DISCUSSION Coordination assessment processes for medical devices and IVDs

      2026-01-27, 5:00 PM

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      Jie Jia
      Senior Medical Director, Fresenius Kabi

      Jie is focused on clinical evidence acquisition-oriented clinical trial organizations and medical affairs management. He provides medical expertise and support throughout product life-cycle, including medical strategy and requirements, clinical evaluation plan and report, HHE, risk analysis and mitigation, and post-market activities. Jie participated in MDR uplift project at the process and product level.

      Experienced in medical & regulatory affairs consulting, familiar with Infusion, Transfusion, and Enteral Nutrition supporting devices, Advanced Hemodynamic Monitoring, orthopedic and dental implants, surgical navigation system, balloon catheter and stent, microscope, lens, and wound closure and healing covers.

      Session Details:

      Planning evaluations that withstand reclassification and scrutiny

      2026-01-28, 11:30 AM

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      Advisory Board

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      Dr Alison McMorn
      PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

      Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, CISCRP

      Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      Aditya Kotta
      Head of Business Development, Novotech

      Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

      Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

      I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Edwin van Vulpen
      Executive Director and Head of Clinical Business Development Euro-Asia
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