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Why Attend

We are excited to welcome you back to the 15th annual Outsourcing in Clinical Trials: Medical Devices Europe. This year’s program follows the full clinical lifecycle of a device — from global study planning and evidence design through execution, regulatory engagement, and post-market data generation. We have also introduced a dedicated In Vitro Diagnostics (IVD) stream, reflecting the growing importance of diagnostics in clinical development

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 30+ 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

2027 Sponsors Include:

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Company Information

1MED, a Specialty MedTech and combination product solutions provider, offering end-to-end development services and digital solutions to MedTech companies across Europe.

Our offerings include preclinical and regulatory support, quality management, clinical trial management, pre and post market trial support, biometrics, medical writing and digital solutions across the clinical research continuum with a cross-functional approach.

In the past 5 years 1Med has supported 500+ different medical devices with certification and shelf life extension.

Visit 1med.net  for more information.

Company Website

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

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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 International LLC (Premier) is a leading global CRO and consulting partner with expertise in driving a smarter, faster path to approval. Our integrated approach helps the life sciences industry turn breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value. 

Company Website

To learn more, please visit our website - https://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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    Agenda

    • 2 Feb 2027
    • 3 Feb 2027
    Expand All

    Streams

    Stream one

    STREAM A: Medical Device Clinical Investigations & Evidence

    Stream two

    STREAM B: In Vitro Diagnostics Performance & Validation

    11:30 AM

    Getting Specimen Strategy Right from the Start

    • Work backwards from the intended purpose, target population and claims to determine which specimens are actually needed
    • Ensure the study population genuinely represents the population described in the intended purpose
    • Forecast how many usable specimens will realistically be available before locking the study design
    • Justify why the number and type of specimens selected are sufficient rather than relying on an arbitrary sample number
    • Plan early for specific claims or patient subgroups that will require sufficient representation in the dataset

    Speakers

    Bruno Golding
    Clinical Development Leader Oncology, Roche Diagnostics

    12 PM

    Reserved for event sponsor

    12:30 PM

    WORKSHOP PART 1 Finding the gaps in your IVD clinical evidence strategy

    • Assess whether each element of the intended purpose is adequately supported by the available evidence
    • Identify gaps in the clinical performance evidence before submission to the Notified Body
    • Decide whether existing evidence can support the intended purpose and claims, or whether new clinical performance data are required
    • Compare where the manufacturer’s assessment of sufficient evidence may differ from the Notified Body’s

    Speakers

    Marta Carnielli
    Head Of Certification, TÜV SÜD

    1 PM

    Lunch and networking

    2 PM

    WORKSHOP PART 2 Closing the gaps in your IVD clinical evidence strategy

    • Work through the evidence gaps identified in Part 1 and determine what additional evidence is actually needed
    • Decide which gaps can be addressed using existing data and which require new clinical performance studies
    • Rework the evidence strategy around the intended purpose, target population and claims Test the revised approach against the questions likely to arise during Notified Body assessment

    Speakers

    Marta Carnielli
    Head Of Certification, TÜV SÜD

    2:30 PM

    Reserved for event sponsor

    3 PM

    From Self-Certification to Notified Body Oversight – What Has IVDR Changed for IVD Manufacturers?

    • What increased Notified Body involvement has changed in practice for IVD manufacturers
    • Where manufacturers are still struggling to adapt their evidence and conformity-assessment strategies
    • What the shift has meant for development timelines, resources and market access
    • What could change again as IVDR continues to evolve

    Els Dequeker, Head of IVD Task Force, Biomed Alliance - TBC

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    PANEL DISCUSSION IVD or Medical Device Software? Getting The Regulatory Pathway Right

    • Work from intended purpose to determine whether software falls under IVDR, MDR or outside either framework
    • Draw the line between software providing health or wellbeing information and software performing a diagnostic function
    • Explore borderline cases where software could potentially qualify as a companion diagnostic
    • Understand how the regulatory pathway changes the evidence and validation strategy
    • Explore what happens when the manufacturer and Notified Body disagree on classification

    Speakers

    Rudy Rigoni
    Regulatory Affairs Manager, Roche Diagnostics
    Samuel Leforestier
    Head of Quality and Regulatory Affaris, Cerebriu

    4:30 PM

    Reserved for event sponsor

    8:15 AM

    Registration and refreshments

    8:45 AM

    Chairperson’s opening remarks

    9 AM

    KEYNOTE SESSION The Next Chapter for Medical Device Regulation in Europe

    • Separating the regulatory changes manufacturers should act on now from proposals that remain under discussion
    • Clarifying what has actually changed and what manufacturers should continue doing under the current framework
    • Identifying the next regulatory milestones that could affect clinical evidence, conformity assessment and market access
    • Giving manufacturers practical guidance on what to prepare now — and what should wait until requirements are confirmed

    9:30 AM

    Reserved for event sponsor

    10 AM

    PANEL DISCUSSION Has MDR/ IVDR Delivered Safer Medical Devices and Diagnostics – And at What Cost?

    • Comparing where MDR and IVDR have strengthened safety and oversight with where additional requirements have created limited clinical value
    • Identifying which requirements are creating the greatest cost, delay and duplication for manufacturers
    • Examining how the regulations have affected device and diagnostic availability, innovation and investment in Europe
    • Testing whether proposed reforms address the problems manufacturers and notified bodies are actually experiencing

    Speakers

    Surash Surash
    Senior Clinical Reviewer and Subject Matter Expert, TÜV SÜD
    Max G. Ostermeier
    CEO and Founder, Implandata Ophthalmic Products

    10:30 AM

    Reserved for event sponsor

    11 AM

    Morning refreshments and networking

    11:30 AM

    Designing PMCF Studies That Actually Close the Evidence Gap

    • Defining the exact evidence gap the PMCF activity needs to close before deciding what data to collect
    • Selecting endpoints, populations and follow-up that generate evidence usable in the clinical evaluation rather than simply producing more data
    • Deciding when a new PMCF study, registry, survey or existing real-world evidence is the most appropriate way to answer the question
    • Building a realistic data-access plan when hospitals, clinicians or other third parties control the information required
    • Avoiding PMCF activities that consume time and budget without answering the question the notified body actually needs addressed

    Speakers

    Claudia Vimercati
    Product Manager – Medical, TÜV Rheinland Italia

    12 PM

    Reserved for event sponsor

    12:30 PM

    Will FDA Accept Your European Evidence?

    • Understanding when European clinical data can support an FDA submission – and what role it can realistically play
    • Distinguishing evidence expectations across different FDA pathways and device types
    • Identifying where European data can be used as supportive evidence and where additional US data may still be needed
    • Using pre-submission discussions to test your evidence strategy before committing to another study
    • Building a global evidence plan that avoids unnecessary duplication, cost and delays

    Speakers

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

    1 PM

    Lunch and networking

    2 PM

    Too much data, not enough insight – are we missing the signals that matter?

    • Turning large volumes of registry, complaint and post-market information into structured data that teams can actually interrogate
    • Using automation to triage thousands of reports and identify which potential signals require expert review
    • Setting criteria for escalating a potential signal into the formal risk-management process
    • Feeding identified trends back into clinical evaluation, risk management and future product-development decisions

    Kolja Boese, Global Medical Director, Smith & Nephew - TBC

    2:30 PM

    Reserved for event sponsor

    3 PM

    PANEL DISCUSSION Where is the Best Place to Launch Your Medical Device First?

    • Comparing Europe, the US and other potential first markets against regulatory timelines, evidence requirements, study cost, patient access and commercial opportunity
    • Challenging outdated assumptions about which countries are still faster, cheaper or easier before building them into development plans
    • Working backwards from the markets the company ultimately wants to enter to identify which evidence can be generated once and where additional work may still be needed
    • Building a market-entry sequence around available capital and runway rather than funding every regulatory programme simultaneously

    Speakers

    Richard Holborow
    Global Head Clinical Compliance, BSI
    Dr. Manuela Stauss-Grabo
    Senior Vice President and Head of Clinical Research, Fresenius Medical Care
    Robin Demesmaeker
    Chief Technology Officer, Compremium

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    Making Clinical Evidence Work Beyond Regulatory Approval

    • Define what the evidence needs to achieve before designing the study
    • Align endpoints with regulatory, clinical and commercial needs.
    • Test whether the data will support the product's real-world use case
    • Spot evidence gaps before the protocol is locked

    Speakers

    Juan de Dios Martin Lujan Palacios
    Clinical Specialist, B. Braun Medical

    4:30 PM

    Reserved for event sponsor

    5 PM

    MDR and IVDR across Europe – what is fragmentation costing clinical development?

    • Using coordinated assessment for MDR clinical investigations and IVDR performance studies
    • Understanding what can be coordinated and what still remains country-specific
    • Navigating national and ethics requirements without duplicating work
    • Preparing submissions to make the coordinated pathway work in practice

    Speakers

    Nebojsa Serafimovic
    Assessor Medical Devices, Senior Expert, Austrian Agency for Health and Food Safety

    5:30 PM

    Chairperson’s closing remarks

    8:15 AM

    Registration and Refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    Alex Booth
    Host, Lab to Lives Podcast

    9 AM

    EXECUTIVE PANEL DISCUSSION Where Do You Put Your Money When You Can’t Fund Everything?

    • Rank competing studies, markets and development programmes
    • Decide what to accelerate, pause, deprioritise or stop
    • Reassess programmes when timelines or evidence requirements change
    • Compare capital decisions across startup, mid-sized and large-company portfolios

    Moderator Alex Booth, Host, Lab to Lives Podcast

    Speakers

    Alex Booth
    Host, Lab to Lives Podcast
    Max G. Ostermeier
    CEO and Founder, Implandata Ophthalmic Products
    Marius Rummel
    Chief Business Officer, Angiolutions
    Robin Demesmaeker
    Chief Technology Officer, Compremium

    9:30 AM

    Reserved for event sponsor

    10 AM

    INVESTOR PANEL DISCUSSION What Evidence Makes a Medical Device Worth Funding?

    • Identifying the clinical and regulatory milestones investors expect to see at different financing stages
    • Understanding which evidence can materially de-risk can an investment and which is simply expected regulatory groundwork
    • Testing whether another clinical study is likely to increase company value enough to justify its cost
    • Putting a real investment scenario in front of the panel and hearing what they would challenge before committing capital

    Moderator: Alex Booth, Host, Lab to Lives Podcast

    Speakers

    Alex Booth
    Host, Lab to Lives Podcast
    Philipp Mayer
    MedTech Investor & Business Angel

    10:30 AM

    Reserved for event sponsor

    11 AM

    Morning refreshments and networking break

    11:30 AM

    When Does a Device Change Require New Clinical Evidence?

    • Understanding when existing clinical evidence can still support a changed device – and when additional evidence becomes necessary
    • Looking at the current MDR expectations around clinical evaluation and demonstrating continued safety and performance
    • Exploring where the framework may be heading and what the evolving MDR could mean for clinical evidence requirements
    • Building a clinical strategy now that is flexible enough to accommodate future regulatory expectations
    • Avoiding unnecessary clinical investigations where existing evidence can adequately answer the regulatory question

    Speakers

    Basira Evard
    Senior Manager Clinical Science, Teleflex

    12 PM

    Reserved for event sponsor

    12:30 PM

    PANEL DISCUSSION Are In Silico clinical trials (ISCT) the new future for clinical investigations?

    • The economic impact of conventional human trials versus’ s In Silico adoption
    • How are In Silico models created? From concept to trials
    • The real world application of In Silico – what is the practical application of In Silico in medical device development?
    • The regulatory pathway to In Silico acceptance

    Speakers

    Surash Surash
    Senior Clinical Reviewer and Subject Matter Expert, TÜV SÜD
    Okan Avci
    Head of Research Group ‘In-Silico Human Modelling & Simulation’, Fraunhofer Institute for Manufacturing Engineering and Automation IPA
    Philippe Favre
    Research Associate Director, Zimmer Biomet

    1 PM

    Lunch and networking

    2 PM

    Where the Trials Are Going: Sector Market Sizing and Deal Signals in MedTech Clinical Development

    • Identifying where clinical trial demand is growing across key medtech sectors
    • Understanding which capabilities sponsors are prioritising through M&A, licensing and strategic investment
    • Pinpointing high-growth areas and emerging opportunities across the medtech clinical trial landscape

    Speakers

    Andrew Thompson
    Director of Therapy Research & Analysis, Medical Devices, GlobalData

    2:30 PM

    Reserved for event sponsor

    3 PM

    Building Clinical Evidence Behind AI-Enabled Medical Devices

    • Understanding what it takes to validate AI-enabled devices across different jurisdictions
    • Building a validation strategy around intended use and clinical practice
    • Determining what data are needed to demonstrate clinical performance
    • Deciding when in-house validation is sufficient and when a clinical study is needed
    • Preparing the evidence strategy for future releases and evolving AI Act requirements

    Speakers

    Helena Neves
    Regulatory Affairs Specialist, 3shape

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    PANEL DISCUSSION Where Does the Human Still Add Value When AI Does the Work?

    • Where AI can draft, extract, summarise or analyse effectively
    • Where scientific judgement is still required to decide whether evidence is sufficient
    • How to challenge AI outputs, assumptions and missing context
    • What makes a scientific conclusion credible rather than simply well written

    Kolja Boese, Global Medical Director, Smith & Nephew - TBC

    Speakers

    Fariba Kafil
    Regulatory Affairs Specialist, 3shape
    Samuel Leforestier
    Head of Quality and Regulatory Affaris, Cerebriu
    Basira Evard
    Senior Manager Clinical Science, Teleflex

    4:45 PM

    End of conference

    Speakers

    Select a speaker to learn more

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    Max G. Ostermeier
    CEO and Founder, Implandata Ophthalmic Products

    Session Details:

    PANEL DISCUSSION Has MDR/ IVDR Delivered Safer Medical Devices and Diagnostics – And at What Cost?

    2027-02-02, 10:00 AM

    Session Details:

    EXECUTIVE PANEL DISCUSSION Where Do You Put Your Money When You Can’t Fund Everything?

    2027-02-03, 9:00 AM

    View In Agenda
    Next speaker
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    Surash Surash
    Senior Clinical Reviewer and Subject Matter Expert, TÜV SÜD

    Session Details:

    PANEL DISCUSSION Has MDR/ IVDR Delivered Safer Medical Devices and Diagnostics – And at What Cost?

    2027-02-02, 10:00 AM

    Session Details:

    PANEL DISCUSSION Are In Silico clinical trials (ISCT) the new future for clinical investigations?

    2027-02-03, 12:30 PM

    View In Agenda
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    Helena Neves
    Regulatory Affairs Specialist, 3shape

    Session Details:

    Building Clinical Evidence Behind AI-Enabled Medical Devices

    2027-02-03, 3:00 PM

    View In Agenda
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    Fariba Kafil
    Regulatory Affairs Specialist, 3shape

    Session Details:

    PANEL DISCUSSION Where Does the Human Still Add Value When AI Does the Work?

    2027-02-03, 4:00 PM

    View In Agenda
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    Marius Rummel
    Chief Business Officer, Angiolutions

    Session Details:

    EXECUTIVE PANEL DISCUSSION Where Do You Put Your Money When You Can’t Fund Everything?

    2027-02-03, 9:00 AM

    View In Agenda
    Next speaker
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    Okan Avci
    Head of Research Group ‘In-Silico Human Modelling & Simulation’, Fraunhofer Institute for Manufacturing Engineering and Automation IPA

    Session Details:

    PANEL DISCUSSION Are In Silico clinical trials (ISCT) the new future for clinical investigations?

    2027-02-03, 12:30 PM

    View In Agenda
    Next speaker
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    Philippe Favre
    Research Associate Director, Zimmer Biomet

    Session Details:

    PANEL DISCUSSION Are In Silico clinical trials (ISCT) the new future for clinical investigations?

    2027-02-03, 12:30 PM

    View In Agenda
    Next speaker
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    Juan de Dios Martin Lujan Palacios
    Clinical Specialist, B. Braun Medical

    Session Details:

    Making Clinical Evidence Work Beyond Regulatory Approval

    2027-02-02, 4:00 PM

    View In Agenda
    Next speaker
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    Claudia Vimercati
    Product Manager – Medical, TÜV Rheinland Italia

    Session Details:

    Designing PMCF Studies That Actually Close the Evidence Gap

    2027-02-02, 11:30 AM

    View In Agenda
    Next speaker
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    Basira Evard
    Senior Manager Clinical Science, Teleflex

    Session Details:

    When Does a Device Change Require New Clinical Evidence?

    2027-02-03, 11:30 AM

    Session Details:

    PANEL DISCUSSION Where Does the Human Still Add Value When AI Does the Work?

    2027-02-03, 4:00 PM

    View In Agenda
    Next speaker
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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 Where is the Best Place to Launch Your Medical Device First?

    2027-02-02, 3:00 PM

    View In Agenda
    Next speaker
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    Nebojsa Serafimovic
    Assessor Medical Devices, Senior Expert, Austrian Agency for Health and Food Safety

    Nebojsa Serafimovic is Head of Unit for Clinical Investigations and Performance Studies at the Austrian Federal Office for Safety in Health Care (AGES/BASG).
    In this role, he is responsible for the regulatory oversight and assessment of clinical investigations with medical devices and performance studies with in vitro diagnostics and plays a key role in shaping both national and European regulatory processes related to the implementation of the MDR and IVDR. His work includes active involvement in EU-level coordination and harmonisation initiatives, notably as Lead of the EUDAMED Oversight CA Board (CIPS), Co-Lead of the work package on coordinated assessment under MDR Article 78, and Co-Lead in one of the COMBINE projects, focusing on the interface between clinical investigations of medical devices/IVDs and medicinal products.
    Previously, he worked at Philips Austria in medical device engineering and at the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM Vienna.
    Nebojsa is an active member of the Clinical Investigation and Evaluation Working Group (CIEPSE) and contributes to several European task forces aimed at further developing and harmonising the regulatory framework for clinical investigations in Europe.

    Session Details:

    MDR and IVDR across Europe – what is fragmentation costing clinical development?

    2027-02-02, 5:00 PM

    View In Agenda
    Next speaker
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    Dr. Manuela Stauss-Grabo
    Senior Vice President and Head of Clinical Research, Fresenius Medical Care

    Session Details:

    Will FDA Accept Your European Evidence?

    2027-02-02, 12:30 PM

    Session Details:

    PANEL DISCUSSION Where is the Best Place to Launch Your Medical Device First?

    2027-02-02, 3:00 PM

    View In Agenda
    Next speaker
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    Rudy Rigoni
    Regulatory Affairs Manager, Roche Diagnostics

    Session Details:

    PANEL DISCUSSION IVD or Medical Device Software? Getting The Regulatory Pathway Right

    2027-02-02, 4:00 PM

    View In Agenda
    Next speaker
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    Bruno Golding
    Clinical Development Leader Oncology, Roche Diagnostics

    Session Details:

    Getting Specimen Strategy Right from the Start

    2027-02-02, 11:30 AM

    View In Agenda
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    Samuel Leforestier
    Head of Quality and Regulatory Affaris, Cerebriu

    Session Details:

    PANEL DISCUSSION IVD or Medical Device Software? Getting The Regulatory Pathway Right

    2027-02-02, 4:00 PM

    Session Details:

    PANEL DISCUSSION Where Does the Human Still Add Value When AI Does the Work?

    2027-02-03, 4:00 PM

    View In Agenda
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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:

    WORKSHOP PART 1 Finding the gaps in your IVD clinical evidence strategy

    2027-02-02, 12:30 PM

    Session Details:

    WORKSHOP PART 2 Closing the gaps in your IVD clinical evidence strategy

    2027-02-02, 2:00 PM

    View In Agenda
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    Alex Booth
    Host, Lab to Lives Podcast

    Session Details:

    Chairperson’s opening remarks

    2027-02-03, 8:45 AM

    Session Details:

    EXECUTIVE PANEL DISCUSSION Where Do You Put Your Money When You Can’t Fund Everything?

    2027-02-03, 9:00 AM

    Session Details:

    INVESTOR PANEL DISCUSSION What Evidence Makes a Medical Device Worth Funding?

    2027-02-03, 10:00 AM

    View In Agenda
    Next speaker
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    Robin Demesmaeker
    Chief Technology Officer, Compremium

    Session Details:

    EXECUTIVE PANEL DISCUSSION Where Do You Put Your Money When You Can’t Fund Everything?

    2027-02-03, 9:00 AM

    Session Details:

    PANEL DISCUSSION Where is the Best Place to Launch Your Medical Device First?

    2027-02-02, 3:00 PM

    View In Agenda
    Next speaker
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    Philipp Mayer
    MedTech Investor & Business Angel

    Session Details:

    INVESTOR PANEL DISCUSSION What Evidence Makes a Medical Device Worth Funding?

    2027-02-03, 10:00 AM

    View In Agenda
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    Andrew Thompson
    Director of Therapy Research & Analysis, Medical Devices, GlobalData

    Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare.

    Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

    Session Details:

    Where the Trials Are Going: Sector Market Sizing and Deal Signals in MedTech Clinical Development

    2027-02-03, 2:00 PM

    View In Agenda
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    Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

    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, Center for Information & Study on Clinical Research Participation (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
    VP Business Development, Novotech

    Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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

    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, Keenova

    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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    Plan Your Visit

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    SPONSORSHIP ENQUIRIES

    Senior Sponsorship Manager

    Alex Purnell


    +44 204540 7786

    SPEAKING OPPORTUNITIES

    Principal Producer

    Ralitsa Pashkuleva


    +44 207661 906

    MARKETING ENQUIRIES

    Head of Marketing

    Karina Gomez


     

    DELEGATE ENQUIRIES

    VIP Delegate Manager

    Sunny Saikia