12th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2024

Hear fresh insight on regulatory changes and hottest technologies impacting European MedTech trials

30 - 31

January

2024
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary
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Featured Speakers

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Pavel Kusnierik​

Head, Regulatory Affairs, Contipro

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Harald Schnidar​

Chief Executive Officer, Scarletred

Harald is the CEO, Founder and President of SCARLETRED, the global technology leader in AI assisted remote skin monitoring, image analysis, and digital health services for biopharma, cosmetics, and medical industries. With over 10 years of experience in leading and growing SCARLETRED, he has successfully established the CE medical device certified platform Scarletred®Vision as a B2B SaaS solution that enables objective and quantitative assessment of visual skin parameters, such as erythema, pigmentation, lesion size, and tissue patterns.

As a visionary and passionate entrepreneur, Harald has a strong track record of innovation, collaboration, and impact in the fields of digital health and AI, biopharma R&D, medical device wearables, cosmeceuticals, and teledermatology. He has developed and patented novel methods for assessing erythema, published in prestigious journals such as Cell and Oncogene, and received multiple awards and honors, such as the Born Global Champion Award and the Most Disruptive Silicon Valley MedTech Newcomer. Hismission is to leverage the power of AI and data to improve skin health outcomes and quality of life for millions of people around the world.

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Heinrich Martens​

Vice President Regulatory Affairs, BU INS, Fresenius Kabi MedTech

Heinrich Martens, VP Regulatory Affairs, hasmore than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.

Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.

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Yvonne Hoogeveen​

Director, Clinical Affairs, Wellinq

Yvonne is Director of Clinical Affairs at Wellinq, which is a Dutch high tech company founded in 2011. Two of Wellinq's constituent elements, PendraCare International and Blue Medical Devices, produce solely medical devices under own brand or OEM-solutions. The third, Sentron, produces sensors, which also have an additional market outside of medicine in general industry.

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Carine Cochereau​

Regulatory International (OUS) Vice President, Integra LifeSciences

Carine Cochereau holds a Pharmacist PHD and a MBA in Industry management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs.

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Sandra Koehler​

Director, Clinical Operations, Xeltis

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    Why attend?

    Join us at the 12th annual Outsourcing in Clinical Trials: Medical Devices Europe conference! Gather fresh insights into regulatory updates, trial-running techniques for small companies, and the latest innovations.

    With presentations and panel discussions on industry trends and outsourcing challenges, this 2-day event is a must-attend for the European medical device and diagnostics community. Network with industry peers, collaborate with trial sponsors, manufacturers, and vendors, and tackle post-MDR challenges together.

    Don’t miss this key opportunity to succeed in a challenging industry!

    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

    120+

    Attendees

    		20+

    Exhibitors

    		20+

    Speakers
    120+

    Attendees

    		20+

    Exhibitors
    20+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 30 Jan 2024
    • 31 Jan 2024
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    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    9 AM

    The AI revolution in medical devices trials: accelerating data analysis in clinical trials

    • Understanding the need for AI and software incorporation to handle paperwork efficiently
    • Exploring the potential for AI to make processes more efficient and improve patient outcomes
    • Exploring the use of AI in accelerating data analysis during clinical trials
    • Discussing how AI-powered data analysis can speed up clinical trial timelines
    • Identifying opportunities for optimising trial efficiency through AI
    • Discussing the benefits of AI in streamlining regulatory compliance

    Speakers

    9:30 AM

    Session reserved for Medidata

    10 AM

    Optimising trial endpoints and endpoint selection in medical device trials

    • Understanding the significance of selecting appropriate trial endpoints for study success
    • Addressing challenges faced by midsize and small companies in conducting large-scale trials
    • Highlighting the need to consider alternative endpoints for trials with limited resources
    • Identifying essential information needed to demonstrate device safety and performance
    • Discussing the interplay between regulatory requirements, safety considerations, and product development goals

    Speakers

    10:30 AM

    Session reserved for featured sponsor

    11 AM

    Morning refreshments and networking break

    11:30 AM

    Expanding horizons, exploring the opportunities and challenges of moving trials abroad

    • Comparing advantages and challenges of running trials in smaller countries vs established trial hubs.
    • Analysing the significance of a comprehensive global strategy for clinical trials
    • Addressing the rationale behind prioritising MDR compliance over US market entry
    • Top tips and tricks for successful international expansion
    • Evaluating the feasibility of running trials in multiple regions simultaneously

    Speakers

    12 PM

    Session reserved for 1MED

    12:30 PM

    Clinical digitalization success for medical device companies

    • Outlining the specific digital transformation goals and requirements for medical device companies
    • Overcoming operational challenges associated with medium-sized medical device companies
    • Detailing a roadmap for successful clinical digitalization

    Speakers

    1 PM

    Lunch and networking

    2 PM

    Navigating the challenges of post-market clinical follow-up studies for drug-device combination products

    • Understanding the concept of PMCF studies mandated by EU MDR
    • Working closely with notified bodies to comply with guidelines and regulations
    • Use cases and best practice for medical device and drug-device combination products

    Speakers

    2:30 PM

    Session reserved for SMART-TRIAL by Greenlight Guru

    3 PM

    PANEL DISCUSSION: Effective collaboration for maximising synergy while working alongside CROs in medical device development

    • Understanding the benefits of working with CROs in medical device development
    • Identifying common challenges faced while working with CROs
    • Promoting open communication channels for effective problem-solving
    • Defining clear roles and responsibilities to avoid overlap and confusion
    • Identifying potential risks associated with collaboration and outsourcing
    • Strategies for building long-term partnerships with CROs

    Speakers

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    Optimising outsourcing strategies: balancing in-house capabilities, CRO selection, and the role of people in successful partnerships

    • Addressing the critical decision of whether to completely outsource or retain some aspects in-house
    • Understanding the advantages and challenges of each approach
    • Discussing strategies for efficiently managing multiple CRO partnerships
    • Identifying ways to find a balance between cost and quality in outsourcing
    • Exploring the range of services and expertise offered by different CROs
    • Strategies for effective contract negotiations with CROs
    • Understanding the value of building strong, long-term partnerships with CROs

    Speakers

    4:30 PM

    Session reserved for GCP-Service International

    5 PM

    Notified Body´s perspective on clinical data generation within the medical device life cycle

    • Presenting updates on regulatory trends and changes in clinical investigations for medical devices
    • Identifying gaps in outsourcing: Safeguarding expertise for outsourcing and robustness of outsourced activities
    • Harmonization in quality assurance of clinical data

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    8:15 AM

    Registration and refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    9 AM

    Best practices, utilising a pragmatic approach to CRF development

    • Emphasising the importance of pragmatic CRF development to meet MDR requirements
    • Recognising the challenges posed by complex CRFs with multiple effective endpoints
    • Sharing real-life experiences and challenges encountered during endpoint selection
    • Strategies for simplifying CRFs to improve data collection and trial management

    Speakers

    9:30 AM

    Session reserved for Premier Research

    10 AM

    Navigating reimbursement challenges in clinical trials: insights on contract negotiations and site compensation

    • Understanding the reimbursement structure and its importance in clinical trials
    • Variances in reimbursement across sites and countries, case studies highlighting the differences in reimbursement models
    • Streamlining contract negotiations, mitigating delays and potential roadblocks
    • Identifying common challenges faced during the negotiation phase
    • Exploring potential developments and innovations in reimbursement strategies

    Speakers

    10:30 AM

    Session reserved for Q Serve

    11 AM

    Morning refreshments and networking

    11:30 AM

    Data lifecycle in clinical investigation: manufacturer’s perspective

    • Is it possible to have efficient data collection from investigators and sites?
    • Statistics fascinating transforming of collected data or boring evil necessity?
    • Possibilities to assess reliability of collected and processed data
    • Understanding statistical reports and issues with results interpretation
    • EU MDR requirements on data in clinical investigations

    Speakers

    12 PM

    Notified Body´s perspective on clinical data generation within the medical device life cycle

    • Presenting updates on regulatory trends and changes in clinical investigations for medical devices
    • Identifying gaps in outsourcing: safeguarding expertise for outsourcing and robustness of outsourced activities
    • Harmonization in quality assurance of clinical data

    Speakers

    12:30 PM

    Real-world data collection: making the most of what’s already available

    • Understanding the importance of collecting real-world data for medical devices
    • Sharing best practices and case studies on leveraging real-world data for device improvement
    • Laying out a plan in early stages of what you can do post-market

    Speakers

    1 PM

    Lunch and networking

    2 PM

    Lessons learned: performance evaluation requirements according to IVDR

    Speakers

    2:30 PM

    Diving into market entry for the global market compared to an EU focused approach

    • Highlighting the benefits of gaining a comprehensive understanding of global market dynamics
    • Discussing strategies for registering products in various global markets
    • Examining trial design strategies based on target markets and regulatory requirements

    Speakers

    3 PM

    Trends and themes in medical device clinical trials: how to stay ahead of the curve

    • Medical device clinical trials in Europe: an overview of the landscape
    • Innovation and technology: what’s new, and what’s upcoming?
    • Changes in technology, strategy and regulatory affairs for the European medical device industry

    Speakers

    3:30 PM

    Afternoon refreshments and networking

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

    4 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into four ‘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 clinical operations.

    ROUNDTABLE 1: Handling relationships between sponsors and vendor

    ROUNDTABLE 2: Reserved for Lumis International

    ROUNDTABLE 3: Key challenges in post-market clinical studies

    ROUNDTABLE 4: Navigating CRO and vendor relationships

    Speakers

    5 PM

    Chairperson’s closing remarks

    Speakers

    END OF CONFERENCE – SEE YOU NEXT YEAR

    Speakers

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    John Shillingford
    Director, Clinical Research, Afon Technology

    John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany.

    His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes.

    John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH.

    Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

    Session Details:

    Chairperson’s opening remarks

    2024-01-31, 8:45 AM

    Session Details:

    Chairperson’s opening remarks

    2024-01-30, 8:50 AM

    Session Details:

    Chairperson’s closing remarks

    2024-01-30, 5:30 PM

    Session Details:

    Chairperson’s closing remarks

    2024-01-31, 5:00 PM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-01-31, 4:00 PM

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    Pavel Kusnierik
    Head, Regulatory Affairs, Contipro

    Session Details:

    Data lifecycle in clinical investigation: manufacturer’s perspective

    2024-01-31, 11:30 AM

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    Heinrich Martens
    Vice President Regulatory Affairs, BU INS, Fresenius Kabi MedTech

    Heinrich Martens, VP Regulatory Affairs, hasmore than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.

    Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.

    Session Details:

    Navigating the challenges of post-market clinical follow-up studies for drug-device combination products

    2024-01-30, 2:00 PM

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    Jie Jia
    Medical Director, BU INS, Fresenius Kabi MedTech

    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:

    Optimising trial endpoints and endpoint selection in medical device trials

    2024-01-30, 10:00 AM

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    Balint Feher
    eClinical Lead, Geistlich Pharma AG

    Balint Feher is a senior clinical research manager at Geistlich Pharma AG. He leads eClinical project at Geistlich, supporting the organization to redesign processes and transition to digital arena. He holds PharmD at Semmelweis University, Budapest and double MSc in computer science and biomedical engineering fields. He has 15+ years’ clinical and 5+ years’ IT expertise in pharma and medical devices industries. Balint’s passion lies in the intersection of clinical, regulatory and IT by leading projects where team can solve complex problems needed combined skillset also at project lead’s level.

    Session Details:

    Clinical digitalization success for medical device companies

    2024-01-30, 12:30 PM

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    Sonnika Lamont
    GlobalData Analyst – Trials Intelligence, GlobalData

    Session Details:

    PANEL DISCUSSION: Effective collaboration for maximising synergy while working alongside CROs in medical device development

    2024-01-30, 3:00 PM

    Session Details:

    Trends and themes in medical device clinical trials: how to stay ahead of the curve

    2024-01-31, 3:00 PM

    View In Agenda
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    Stefan Meyer
    Chief Technology Officer, Implandata Ophthalmic Products

    Stefan Meyer is co-founder and CTO of Implandata Ophthalmic Products GmbH. He has more than fifteen years of experience in development of novel medical products meeting regulatory standards and market acceptance criteria.

    He was co-founder of Cranium Telemetrics GmbH, a medical technology company with innovative neuro-surgery products whose technology was acquired 4 year after foundation by a leading US medical device company. Thereafter he was responsible for technology transfer to this company. Stefan Meyer was instrumental in developing Implandata Ophthalmic Products GmbH’s technology platform and utilizing this platform for products within medical applications. He is author of multiple medical technology patents.

    Session Details:

    Optimising outsourcing strategies: balancing in-house capabilities, CRO selection, and the role of people in successful partnerships

    2024-01-30, 4:00 PM

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    Carine Cochereau
    Regulatory International (OUS) Vice President, Integra LifeSciences

    Carine Cochereau holds a Pharmacist PHD and a MBA in Industry management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs.

    Session Details:

    Expanding horizons, exploring the opportunities and challenges of moving trials abroad

    2024-01-30, 11:30 AM

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    Shauna Coen
    Senior Regulatory Affairs Specialist, iThera Medical GmbH

    Shauna is a versatile QM/RA professional, with extensive experience in project management, supporting research and development, developing clinical evaluations and associated documentation, facilitating new product introduction, optimising manufacturing operations, obtaining market access, and leading post-market surveillance activities. A validation subject matter expert with 10 years of hands-on validation experience, decision-making and a Major in Process Validation.

    Session Details:

    Diving into market entry for the global market compared to an EU focused approach

    2024-01-31, 2:30 PM

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    Deborah-Ann Schuster
    Clinical Project Manager, Hospital Patient Monitoring, Philips

    Session Details:

    Navigating reimbursement challenges in clinical trials: insights on contract negotiations and site compensation

    2024-01-31, 10:00 AM

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    Aude Yulzari
    Clinical Affairs Manager, Precisis

    Session Details:

    Real-world data collection: making the most of what’s already available

    2024-01-31, 12:30 PM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-01-31, 4:00 PM

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    Danish Mairaj
    Principal Engineer Medical Device Design, Resyca

    Session Details:

    The AI revolution in medical devices trials: accelerating data analysis in clinical trials

    2024-01-30, 9:00 AM

    View In Agenda
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    Ya-Hsuan Lin
    R&D Project Manager, SciVision Biotech

    Session Details:

    Best practices, utilising a pragmatic approach to CRF development

    2024-01-31, 9:00 AM

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    Anna Mayer
    Clinical Auditor, TÜV SÜD

    Session Details:

    Notified Body´s perspective on clinical data generation within the medical device life cycle

    2024-01-30, 5:00 PM

    Session Details:

    Notified Body´s perspective on clinical data generation within the medical device life cycle

    2024-01-31, 12:00 PM

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    Marta Carnielli
    Head Of Certification, TÜV SÜD

    Session Details:

    Lessons learned: performance evaluation requirements according to IVDR

    2024-01-31, 2:00 PM

    View In Agenda
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    Sandra Koehler
    Director, Clinical Operations, Xeltis

    Session Details:

    PANEL DISCUSSION: Effective collaboration for maximising synergy while working alongside CROs in medical device development

    2024-01-30, 3:00 PM

    View In Agenda
    Next speaker
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    Harald Schnidar
    Chief Executive Officer, Scarletred

    Harald is the CEO, Founder and President of SCARLETRED, the global technology leader in AI assisted remote skin monitoring, image analysis, and digital health services for biopharma, cosmetics, and medical industries. With over 10 years of experience in leading and growing SCARLETRED, he has successfully established the CE medical device certified platform Scarletred®Vision as a B2B SaaS solution that enables objective and quantitative assessment of visual skin parameters, such as erythema, pigmentation, lesion size, and tissue patterns.

    As a visionary and passionate entrepreneur, Harald has a strong track record of innovation, collaboration, and impact in the fields of digital health and AI, biopharma R&D, medical device wearables, cosmeceuticals, and teledermatology. He has developed and patented novel methods for assessing erythema, published in prestigious journals such as Cell and Oncogene, and received multiple awards and honors, such as the Born Global Champion Award and the Most Disruptive Silicon Valley MedTech Newcomer. Hismission is to leverage the power of AI and data to improve skin health outcomes and quality of life for millions of people around the world.

    Next speaker
    Back
    Yvonne Hoogeveen
    Director, Clinical Affairs, Wellinq

    Yvonne is Director of Clinical Affairs at Wellinq, which is a Dutch high tech company founded in 2011. Two of Wellinq's constituent elements, PendraCare International and Blue Medical Devices, produce solely medical devices under own brand or OEM-solutions. The third, Sentron, produces sensors, which also have an additional market outside of medicine in general industry.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-01-31, 4:00 PM

    View In Agenda
    Next speaker

    Plan Your Visit

    Venue

    Holiday Inn Munich City Centre

    Hochstrasse 3 Munich 81669 Germany

    Accommodation

    Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel.

    Sponsors

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    FEATURED SPONSORS

    SESSION SPONSORS

    ROUNDTABLE SPONSORS

    TECHNOLOGY SHOWCASE SPONSOR

    EXHIBITORS

    Resources

    Enquiry

    Contact Us

    SPONSORSHIP ENQUIRIES

    Alex Purnell

    Senior Sponsorship Manager

    +44 204540 7786

    SPEAKING OPPORTUNITIES

    Louisa Manning

    Programme Director

    +44 207661 906

    MARKETING ENQUIRIES

    Moona Popal

    Marketing Manager

    DELEGATE ENQUIRIES

    Sunny Saikia

    VIP Delegate Manager

    SPONSORSHIP ENQUIRIES

    To enquire about sponsorship opportunities for the conference, please contact:

    Alex Purnell

    Senior Sponsorship Manager


    +44 204540 7786

    SPEAKER ENQUIRES

    To enquire about speaking opportunities for the conference, please contact:

    Louisa Manning

    Programme Director


    +44 207661 906