Outsourcing in Clinical Trials: Medical Devices Europe 2023

The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges.

21 - 22

February

2023
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary
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  • Agenda
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Featured Speakers

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Yana Arlouskaya​

Project Manager For Clinical Investigations, Hartmann Group

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Deborah-Ann Schuster​

Clinical Project Manager, Hospital Patient Monitoring, Philips

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Pavel Kusnierik​

Head Of Regulatory Affairs, Contipro

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Laia Casas Papiol​

Clinical Project Leader, Noucor Health

Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

 

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Claire Woodthorpe​

Chief Operating Officer, Lightpoint Medical

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Marta Carnielli​

Head Of Certification, TÜV SÜD

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Karel Volenec​

CEO, ELLA-CS

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Olli Keränen​

CEO, Medtentia

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Carlos Fuste​

Medical Director Spain / France, Fidia Farmaceutici SpA

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Paulo Neves​

Vice President Clinical And Medical Affairs, Xeltis

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Catherine Longworth​

Editor, GlobalData

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Miron Tokarski​

CEO, Genomtec

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    2023 Sponsors Include:

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    Company Information

    1MED is a dynamic and proactive international company providing regulatory support, digital solutions and full-service CRO assistance to the medical device and pharmaceutical industries, concentrating on innovation, continuous improvement, scalability and alignment with regulatory and clinical requirements.

    1MED’s goal is to transform a time-consuming and complex process, such as product approval, into a reliable, more predictable and streamlined process, while still guaranteeing quality and conformity to the applicable regulatory requirements.

    With a unique focus on medical devices and the ability to quickly develop smart and tailor-made solutions, 1MED’s experienced and specialised multidisciplinary team of more than 70 employees is able to meet the increasingly demanding requirements of medical device and in vitro product regulations.

    Thanks to a good and solid relationship with 14 Notified Bodies in the EU, the Swiss-based company has been able to lead more than 500 medical devices to successful CE marking.

    “We are committed to working at your side, designing and implementing highly competitive and affordable strategies precisely because we know, understand and predict your challenges”.

    Company Website

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

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    Company Information

    ECLEVAR a global CRO supports manufacturers in the MDR and IVDR transition. Our team led by former notified body and competent authority leadership is an extension team of medical & regulatory affairs. Our solutions are supported by scientific board of prominent KOLs to supervise and guarantee clinical and scientific validity

    Company Website

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

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    Company Information

    Lumis International GmbH supports non EU-biopharmaceutical companies as their legal representative. Through their daughter company Lumis Life Science Consulting GmbH they provide customer-tailored consulting and solutions for clinical vendor selection and management, clinical trial oversight, quality management, and training. Jointly with our customers, we develop tailored solutions to optimise their clinical development program. We collaborate with a network of experienced subject matter experts, cooperation partners, and consultants.

    Company Website

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

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    Pure Clinical is responsible for a wide range of clinical trials and performance studies with laboratory tests. We operate with MDR/IVDR legal regulations, which allows us to conduct tests at the highest possible level. Pure Clinical experts are developing the most beneficial strategies to bring products to market.

    Company Website

    To learn more , please visit our website - www.pureclinical.eu

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    Company Information

    As member of the QbD group, QbD Clinical is an expert clinical solutions provider specialized in medical devices, offering global CRO services and consultancy.  Partnering with QbD Clinical will ensure that your trials are set-up and executed in full compliance with the new MDR regulations. 

    Company Website

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

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    Company Information

    Qmed Consulting is a global full-service Contract Research Organization (CRO) based in Copenhagen, Denmark. We provide strategic consulting services in connection with medical device approval as well as best-in-class expertise in clinical affairs, regulatory affairs, quality management and commercial healthcare.

    Company Website

    To learn more , please visit our website - http://www.qmed-consulting.com/

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    Company Information

    At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval.

    Company Website

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

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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

    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

    Navigating the process to expedite your product entering China market!

    CCRC (Clinical Consultancy Research Center) is a full-service Medtech CRO (contract research organization) based in China that specialized in Medical Devices, Digital Health, and Drug-Device Combination Products across a wide range of therapeutic areas.

    CCRC is committed to providing end-to-end services including innovative medical device application, regulatory and clinical strategy consulting, preclinical study design and technical consulting, clinical audit, project management, clinical monitoring, medical affairs, biostatistics, data management, product registration and declaration, safety management, research center management, imaging core laboratory, and other services.

    Company Website

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

    Quinten MD is a CRO specialized in medical devices post-market activities. Quinten MD helps its customers to harness the full potential of clinical data, including real-world data, to accelerate their regulatory compliance process. Quinten MD has developed innovative technologies and methodologies, which are leveraged through its different services.

    Company Website

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

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    Company Information

    SMART-TRIAL by Greenlight Guru is a complete data collection toolbox for Post-Market Clinical Follow-Up (PMCF), Post-Market Performance Follow-Up (PMPF), Clinical Investigations, and Clinical Performance Studies. Collect and manage your clinical data in the only EDC built specifically for the needs of MedTech! 

    Company Website

    To learn more , please visit our website - www.smart-trial.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

    Virtonomy supports medical device developers in accelerating medical device development and clinical trials with the use of digital patient twins and computer simulations to substitute conventional testing in experiments, animals, cadavers, and humans.

    Company Website

    To learn more , please visit our website - https://www.virtonomy.io/

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      Why attend?

      We are excited to welcome you back to the annual Outsourcing in Clinical Trials conference for Medical Devices. This years programme offers a fresh insight into the latest regulatory updates, techniques of running trials for a small company, the latest innovations and many more topics.

      With presentations and panel discussions on all the hottest industry trends and outsourcing challenges, the 2-day event promises to provide the European medical device and diagnostics community with an unmissable opportunity to learn and network to help them succeed in a challenging industry.

      The event will offer a fantastic space to network with your industry peers and discuss the latest challenges we are all facing post MDR. You will also be able to collaborate with the biggest trial sponsors, manufacturers, and vendors from the continent and beyond.

      The meeting place for healthcare pioneers and innovators

      Join medical device experts to discuss new trends and opportunities and learn how to optimize their clinical operation knowledge and stay ahead of the game. Find the right solution providers to partner with to accelerate your trial timelines.

      120+

      Attendees

      		20+

      Exhibitors

      		20+

      Speakers
      120+

      Attendees

      		20+

      Exhibitors
      20+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 21 Feb 2023
      • 22 Feb 2023
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      8 AM

      Registration & Refreshments

      8:55 AM

      Chairman’s Opening Remarks

      9 AM

      How to build a good relationship with your clinical trial site and how it can improve clinical trial performance

      • Highlighting the role that the clinical trial site plays and how to work with the site during the planning phase
      • How to ensure a study will stand out at a clinical trial site
      • Exploring some key advice on how to get the most out of your site
      • Focus points moving forwards, how both CRO’s and sponsors can work with a site to improve the quality of a trial

      Speakers

      9:30 AM

      Preparing for Medical Device Approval: Strategies for Meeting US and European Regulatory Standards

      • Current advancements and projected schedules for EU MDR conformity
      • Tactics for tackling significant obstacles encountered by the industry
      • The digital transition imperative to competently abide by EU MDR regulations and surpass them

      Speakers

      10 AM

      A New Phase In Good Clinical Practice: Are We Ready To Implement All Aspects Of ICO 2020 Requirements?

      • What are the shifts in the scope of requirements on clinical investigations?
      • Working on the connection between Good Clinical Practice requirements together with other standards and MDR?
      • Unveiling experience with dealing with ethics committees and competent authorities under new set of requirements

      Speakers

      10:30 AM

      Morning Refreshments and Networking

      11 AM

      Navigating operational challenges for start-ups starting their clinical journey

      • Exploring all the lessons learned from two digital health start ups
      • Finding committed clinical partners for trials
      • Designing trials for reimbursement, not (only) regulatory
      • From retrospective to prospective trials, from structural to functional endpoints

      Speakers

      11:30 AM

      Post Market Clinical Follow-up: Dealing with the rising costs of clinical trials

      • Why collecting high-quality and relevant data from outside EU can be a cost-effective solution?
      • How do Notify Bodies view data from outside the EU?
      • How to ensure you are collecting high-quality and relevant data from sites outside EU?

      Speakers

      12 PM

      Effectively Using Patient Reported Outcomes (Pros) To Garner Quality Clinical Data

      • Patient Reported Outcomes: the new frontier of real-world evidence
      • Planning and setting up a well-defined process to garner quality data from PROs
      • Addressing ongoing challenges to improve the feasibility of patient reporting
      • Case study – Data collected from patient survey
      • How this survey helped to meet the evidence requirements and demonstrate the safety and performance of the device according to the clinical benefits

      Speakers

      12:30 PM

      Lunch

      1:30 PM

      Is There Any Room For Innovation During The Era Of MDR? Ensuring Competitiveness And Innovation During Uncertain Regulations

      • Understanding the significant impact of MDR on innovation in medical device industry
      • Is the innovation moving to the US: Uncovering the impact of MDR on the European market
      • Assessing practical solutions in compliance with competent authorities and ethics committee

      Speakers

      2 PM

      EU MDR: How Attractive is Europe for Innovation

      • What are the main regulatory challenges for new medical devices after EU MDR?
      • How MedTech companies are reacting?
      • Is CE-mark still "first choice" by start-ups and SMEs

      Speakers

      2:30 PM

      A deep dive into PMCF, exploring a full cycle and the key points at each stage

      • Conception of an idea and moving it forward
      • Seeking the right approval by notified bodies and expert panels
      • Overcoming hurdles in implementation

      Speakers

      3 PM

      Afternoon Networking & Refreshments

      3:30 PM

      Uncovering the benefits of remote monitoring in modern trials

      • Exploring the place that remote trials have in the modern clinical world
      • Reviewing the positives and negative aspects of remote patient and data monitoring
      • What are the operational challenges of reviewing data remotely compared to site visits
      • Do we lose an element of trust when we take away the site relationship?

      Speakers

      4 PM

      Advancing Digital Technologies in Daily Study Management

      • Regulatory requirements and increasing demand for digital technologies
      • Commonly seen digital technologies for study integration
      • Challenges implementing digital technologies
      • The future of digital technologies

      Speakers

      4:30 PM

      Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

      • Does the high levels of bureaucracy prevent innovation driven by smaller firms?
      • Unveiling the impact of liquidity issues on medical device innovation
      • Is there a way out? Tackling the complexity of regulations for the sake of a more innovative medical device industry

      Speakers

      5 PM

      Case Study: How to bring your product out to the market through clinical trials.

      • Finding alternatives outside of the EU and US to start off a clinical cycle
      • Working with first in human trials as a way to prove safety and efficacy
      • The possibilities of working without a CRO at the early stages of clinical testing

      Speakers

      5:30 PM

      Chairman’s Closing Remarks & Drinks Reception

      8:30 AM

      Registration and Refreshments

      8:50 AM

      Chair’s Opening Remarks

      9 AM

      Speaker Hosted Roundtables

      Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

      Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables

      RT1 Discussing The Current Issues With Efficient Supply Chain Management For Clinical Trials Of Medical Devices

      Sandra Kohler, Director of Clinical Ops, Xeltis

      RT2 Addressing The Challenges With MDR: How to Plan the Clinical Investigation for a Medical Device To Generate an Appropriate Evidence Compliant with the New Regulation?

      Yana Arlouskaya, Project Manager for Clinical Investigations, Paul Hartmann AG

      RT3 Developing Effective Procedures For Study Risk Management In Your Medical Device Trial

      Danish Mairaj, Principal Engineer Medical Device Design, Resyca

      RT4 Developing Effective Vendor Management Tools to Oversee Your Clinical Investigation

      Dr Hans-Heinrich Nickell, Business Development Consultant, Lumis Life Science Consulting GmbH

      Speakers

      10 AM

      Morning Refreshments and Networking

      10:30 AM

      Panel: CROs As Partners: How To Find Best CRO According To Your Requirements?

      • Understanding the benefits of long term partnership with CROs
      • How can the CROs help medical manufacturers to expand their studies outside Europe?
      • Ensuring efficient CRO selection: Are CROs up to date with new MDR regulations?
      • Discovering different ways to engage with CROs
      • Unveiling the changing CRO requirements for companies with different sizes

      Speakers

      11 AM

      Finally obtained CE certification, what is needed next?

      • How to collect PMCF clinical data for your device to stay CE marked on the market.
      • What are your options?

      Speakers

      11:30 AM

      Discussing the IVDR state of play with a focus on the challenges of Small/Medium Enterprises

      • Providing a regulatory update on the current field
      • Sharing the current status of transition and how the industry is doing
      • Focusing on the challenges that SMEs face in these trying times

      Speakers

      12 PM

      Defining Sample Size for Pre- and Post-Market Clinical Activities

      • How to justify the sample size
      • How to prepare for sample size calculation
      • How clinical experience influences sample size

      Speakers

      12:30 PM

      Networking Lunch

      1:30 PM

      Case Study – How to improve the outcome of clinical performance studies of IVD products by meeting EN 62366 12015 A12020 standard

      • Discussing some of the main challenges of meeting the new standards with IVD products
      • How to get the most out of your product and ensure that the user is able to work with the device easily

      Speakers

      2 PM

      IVDR and Companion Diagnostics Challenges in Clinical Studies

      • Review the conformity assessment procedure for companion diagnostics
      • Discover the when and how of clinical performance studies, including clinical evidence and
        submission requirements
      • Learn sponsor responsibilities within a companion diagnostics clinical performance study

      Speakers

      2:30 PM

      Growing Trends on the Use of RWE for Clinical Development

      • Understanding how the regulatory landscape is evolving, with growing acceptance of RWE by regulators around the world
      • The increasing usage of Real World Evidence and Real World Data will be explored in a global context

      Speakers

      3 PM

      Fireside Chat: Tackling The Reasons For A Much Needed Change: Benefits Of Inclusive Terminology For Patient Documentation In Med-Device Clinical Trials:

      • A look at current ISF patient documentation policy: Is it really inclusive?
      • How does a gender bias affect the medical device clinical trials?
      • Understanding the benefits of an inclusive terminology for medical devices

      Speakers

      3:30 PM

      Close of Conference

      Speakers

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      Renata Čížková
      Head of Clinical Department, , ELLA-CS

      Session Details:

      Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

      2023-02-21, 4:30 PM

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      Sandra Kohler
      Director Of Clinical Ops, Xeltis

      Session Details:

      Speaker Hosted Roundtables

      2023-02-22, 9:00 AM

      Session Details:

      Panel: CROs As Partners: How To Find Best CRO According To Your Requirements?

      2023-02-22, 10:30 AM

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      Yana Arlouskaya
      Project Manager For Clinical Investigations, Hartmann Group

      Session Details:

      Speaker Hosted Roundtables

      2023-02-22, 9:00 AM

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      Enrico Perfler
      CEO, 1MED SA

      A biomedical engineer by training, Mr. Perfler has 18 years of professional experience specialising in medical device technology and, with his company, has overseen the development and regulatory approval of over 500 medical devices.

      In 2014, he founded 1MED SA, a dynamic international company providing regulatory support, digital solutions and full-service CRO support to the medical device and pharmaceutical industry with a focus on IVD and medical products.

      Mr. Perfler is also a contract professor of “Regulatory Affairs” at University of Pavia, Faculty of Engineering and an active contributor to the ISO technical committee for the biological evaluation of medical devices.

      Session Details:

      EU MDR: How Attractive is Europe for Innovation

      2023-02-21, 2:00 PM

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      Jana Meschede
      Project Manager, ZEISS Medical
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      Danish Mairaj
      Principal Engineer Medical Device Design, Resyca

      Session Details:

      Speaker Hosted Roundtables

      2023-02-22, 9:00 AM

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

      Session Details:

      Is There Any Room For Innovation During The Era Of MDR? Ensuring Competitiveness And Innovation During Uncertain Regulations

      2023-02-21, 1:30 PM

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      Aude Yulzari
      Clinical Affairs Manager, Precisis

      Session Details:

      A deep dive into PMCF, exploring a full cycle and the key points at each stage

      2023-02-21, 2:30 PM

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      Chems Hachani
      CEO, ECLEVAR MEDTECHECH

      Session Details:

      Post Market Clinical Follow-up: Dealing with the rising costs of clinical trials

      2023-02-21, 11:30 AM

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      Luana Clerico
      Clinical & Medical Affairs Director, Polytech

      Session Details:

      Effectively Using Patient Reported Outcomes (Pros) To Garner Quality Clinical Data

      2023-02-21, 12:00 PM

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      Pavel Kusnierik
      Head Of Regulatory Affairs, Contipro

      Session Details:

      A New Phase In Good Clinical Practice: Are We Ready To Implement All Aspects Of ICO 2020 Requirements?

      2023-02-21, 10:00 AM

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      Hans-Heinrich Nickell
      Business Development Consultant, Qmed Consulting

      Dr. Hans-Heinrich Nickell has more than 20 years of experience in clinical development support for pharmaceutical companies, biotech, medical device and vaccine industries. He holds a degree in Pharmacy from the Philipps University in Marburg and a degree for Human Medicine from the Albert-Ludwigs University in Freiburg. After clinical work as a medical doctor at the University Clinic in Lübeck he started his career in 1995 in the pharmaceutical industry working for biotech companies. From 1999 he has worked in Business Development for major CROs with a focus on Medical Devices, CNS, Infectious Diseases, Immunotherapy, Vaccines and Oncology.

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      Laia Casas Papiol
      Clinical Project Leader, Noucor Health

      Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

       

      Session Details:

      Fireside Chat: Tackling The Reasons For A Much Needed Change: Benefits Of Inclusive Terminology For Patient Documentation In Med-Device Clinical Trials:

      2023-02-22, 3:00 PM

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      Fiona Maini
      Senior Director, Global Compliance and Strategy, Medidata

      Session Details:

      Preparing for Medical Device Approval: Strategies for Meeting US and European Regulatory Standards

      2023-02-21, 9:30 AM

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      Claire Woodthorpe
      Chief Operating Officer, Lightpoint Medical

      Session Details:

      Uncovering the benefits of remote monitoring in modern trials

      2023-02-21, 3:30 PM

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      Jón I. Bergsteinsson
      Founder, SMART-TRIAL by Greenlight Guru

      Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón’s primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.

      Session Details:

      Defining Sample Size for Pre- and Post-Market Clinical Activities

      2023-02-22, 12:00 PM

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      Wouter Mattheussens
      Junior Clinical Project Manager, QServe

      Session Details:

      Finally obtained CE certification, what is needed next?

      2023-02-22, 11:00 AM

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      Marta Carnielli
      Head Of Certification, TÜV SÜD

      Session Details:

      Discussing the IVDR state of play with a focus on the challenges of Small/Medium Enterprises

      2023-02-22, 11:30 AM

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      Karel Volenec
      CEO, ELLA-CS

      Session Details:

      Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

      2023-02-21, 4:30 PM

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      Manuel Opitz
      CEO, Deepeye Medical

      Session Details:

      Navigating operational challenges for start-ups starting their clinical journey

      2023-02-21, 11:00 AM

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      Olli Keränen
      CEO, Medtentia

      Session Details:

      Case Study: How to bring your product out to the market through clinical trials.

      2023-02-21, 5:00 PM

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      Carlos Fuste
      Medical Director Spain / France, Fidia Farmaceutici SpA

      Session Details:

      Growing Trends on the Use of RWE for Clinical Development

      2023-02-22, 2:30 PM

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      Paulo Neves
      Vice President Clinical And Medical Affairs, Xeltis

      Session Details:

      How to build a good relationship with your clinical trial site and how it can improve clinical trial performance

      2023-02-21, 9:00 AM

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      Frank Keulen
      Director, Program Delivery, Medical Device and Diagnostics, Premier Research

      Session Details:

      Advancing Digital Technologies in Daily Study Management

      2023-02-21, 4:00 PM

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      Catherine Longworth
      Editor, GlobalData
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      Miron Tokarski
      CEO, Genomtec

      Session Details:

      Case Study – How to improve the outcome of clinical performance studies of IVD products by meeting EN 62366 12015 A12020 standard

      2023-02-22, 1:30 PM

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