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

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

28 - 29

January

2025
  • Munich, Germany
  • Complimentary
  • Why attend?
  • 2024 Agenda
  • 2024 Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
  • Why partner?
  • Contact Us
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Why attend?

The meeting place for healthcare pioneers and innovators

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

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

120+

Attendees

20+

Exhibitors

20+

Speakers

120+

Attendees

20+

Exhibitors

20+

Speakers

2024 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

John Shillingford
Director, Clinical Research, Afon Technology

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

Danish Mairaj
Principal Engineer Medical Device Design, Resyca

9:30 AM

Linking clinical trial and real-world data: the future of medical device development

Medical device and diagnostics manufacturers are under increasing pressure to validate their products' efficacy, safety, and cost-effectiveness across the entire lifecycle. Integrating clinical trials with real-world data (RWD) has emerged as a potent method for solving clinical evidence needs during and after clinical trials. This combined data is collected with minimal site or patient burden and unlocks novel insights into patient trajectories and outcomes, including patients lost to follow-up. This approach also reduces the potential burden on post-market surveillance with faster and deeper insights into patient safety and can lend itself to improved tracking of healthcare utilization.Directly linking trial insights with RWD represents a paradigm shift in how we consider evidence generation for medical device development. This session will explore the requirements, best practices, and latest industry trends in linking clinical trials to RWD.

Speakers

Ben McConnochie
Director, Strategic Development, Acorn AI, Medidata

10 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

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

10:30 AM

Navigating 2024 MDR deadlines: a roadmap for medtech innovation

  • 2024 MDR deadlines
  • 1Med’s expertise in MedTech
  • Compliance tool for MDR Recertification
  • 1Survey: real world data collection

Speakers

Enrico Perfler
Founder, 1Med

11 AM

Morning refreshments and networking break

11:30 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

Jie Jia
Medical Director, BU INS, Fresenius Kabi MedTech

12 PM

Key elements to outsourcing clinical activities in 2024

State of the industry and a cheat sheet to getting it right

  • Results from Greenlight Guru's comprehensive industry survey
  • What you need to know about outsourcing / insourcing your studies
  • What can be outsourced and what can't?
  • Cheat sheet for working with partners

Speakers

Pall Johannesson
Managing Director, Greenlight Guru

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

Balint Feher
eClinical Lead, Geistlich Pharma AG

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

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

2:30 PM

Real World Evidence: the key to easy regulatory compliance?

  • What is Real World Evidence (RWE) and what opportunities does it hold?
  • How to select RWE that can withstand scrutiny?
  • Important considerations when deciding what data to collect
  • Tips on how to draw the right conclusions from RWE

Speakers

Andreas Beust
Chief Executive Officer, GCP-Service International and President, AICROS

2:45 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

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData
Sandra Kohler
Director, Clinical Operations, Xeltis
Abdessamad Belhamdi
Director, Quality and Regulatory Affairs, SPARTHA Medical HQ
Stefan Meyer
Chief Technology Officer, Implandata Ophthalmic Products
Enrico Perfler
Founder, 1Med
Carl Taylor
Sales Director EMEA MedTech, Medidata

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

Stefan Meyer
Chief Technology Officer, Implandata Ophthalmic Products

4:30 PM

Validated mobile health apps for health care improvement

  • Overview of achievements and challenges for clinical research in the digitizing German landscape
  • Potential and proven uses of digital health applications
  • Pitfalls and how these can be mastered
  • CRO remits in clinical investigations

Speakers

Dr Cordula Stover
Senior Medical Writer, RQM+

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

Anna Mayer
Lead Auditor, Non Active Medical Devices, TÜV SÜD

5:30 PM

Chairperson’s closing remarks

Speakers

John Shillingford
Director, Clinical Research, Afon Technology

NETWORKING DRINKS RECEPTION AND END OF DAY 1

8:15 AM

Registration and refreshments

8:45 AM

Chairperson’s opening remarks

Speakers

John Shillingford
Director, Clinical Research, Afon Technology

9 AM

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

Aude Yulzari
Clinical Affairs Manager, Precisis

9:30 AM

The power of clinical data: what medical device developers need to know about MDR Article 61.4

  • An overview of MDR Article 61.4, with a focus on performance and safety requirements for a clinical investigation of implantable and class III devices
  • The impact on claiming equivalence, and the challenges med device sponsors are facing
  • Key considerations for operationalizing medical device clinical investigations to achieve performance and safety data

Speakers

John Thomas
Director, Program Delivery, MedTech, 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

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

10:30 AM

Data management in clinical investigations: improving your study design and the quality of the data

  • Why do we collect clinical data?
  • Setting up a proper CRF
  • Daily data management is key
  • Solving problems when your study is live

Speakers

Wouter Mattheussens
Clinical Project Manager, QServe Group

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

Pavel Kusnierik
Head, Regulatory Affairs, Contipro

12 PM

Learning from Chinese and US authority: comparisons and learnings for the EU

Speakers

Antonio Li
Founder, easychinapprov

12:30 PM

Lunch and networking

1:30 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

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData

2 PM

Lessons learned: performance evaluation requirements according to IVDR

Speakers

Marta Carnielli
Head Of Certification, TÜV SÜD

3:30 PM

Afternoon refreshments and networking

3:55 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: MDR certification for drug-device combination products
Yvonne Hoogeveen, Director, Clinical Affairs, Wellinq

ROUNDTABLE 2: Regulatory pathways for medical device studies: getting your study approved under the MDR
Liam Spencer, Senior Regulatory Project Manager, Lumis International

ROUNDTABLE 3: Key challenges in post-market clinical studies
Aude Yulzari, Senior Clinical Affairs Manager, Precisis

Speakers

Yvonne Hoogeveen
Director, Clinical Affairs, Wellinq
Liam Spencer
Senior Regulatory Project Manager, Lumis International
Aude Yulzari
Clinical Affairs Manager, Precisis
John Shillingford
Director, Clinical Research, Afon Technology

5 PM

END OF CONFERENCE – SEE YOU NEXT YEAR

Additional topic suggestions:

Clinical utility benefit-risk analysis, unravelling insights through case studies and real-world experiences

  • Understanding the significance of clinical utility benefit-risk analysis in medical decision-making.
  • Identifying strategies to strike a balance between benefits and potential risks for early stage trials
  • Presenting examples of actual benefit-risk assessments in clinical settings
  • Addressing common challenges encountered during benefit-risk analysis
  • Demonstrating how benefit-risk analysis contributes to improved patient safety and treatment effectiveness 

Unleashing the potential of software and AI as medical devices, key learnings, innovations, and overcoming obstacles

  • Exploring the growing interest in using software and AI in medical applications
  • Discussing the challenges and considerations in testing and regulating AI-powered devices
  • Understanding the potential impact on medical imaging and other healthcare fields
  • Identifying unique challenges and opportunities in this evolving field
  • Discussing the impact of AI on treatment planning and decision-making
  • Addressing common obstacles faced during software and AI implementation and approval
  • Understanding the regulatory landscape for AI-driven medical devices
  • Anticipating upcoming innovations and trends in the AI space

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

  • Understanding the increasing trend of combining medical devices and drugs
  • Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
  • Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
  • Identifying compliance requirements and implications based on the device's primary mode of action
  • Presenting various regulatory pathways available for combination products
  • Understanding how partnerships can drive innovation and development in this domain

Exploring ways to leverage CRO expertise and innovation in medical device development 

Adapting clinical trials post-covid: lessons learned, decentralised trials, and preparing for the future

  • Understanding the importance of adapting trial systems for future preparedness
  • Understanding the impact of technology in enabling remote and decentralised trial operations
  • Discussing how DCT can improve trial efficiency and patient participation
  • Discussing potential advancements in decentralised and remote trial approaches

Advancing pre-clinical talks, exploring design development, risk management, and usability in medical device development

  • Discussing how certain aspects contribute to the success of medical device development
  • Highlighting the importance of incorporating risk management strategies in device development
  • Emphasising the value of usability considerations to enhance product performance and user experience
  • Presenting case studies showcasing successful product journeys and development processes.
  • Identifying when and what changes may require conducting new trials

Navigating notified bodies: looking at best practices, soft skills, and understanding the NB perspective in medical device registration

  • Exploring strategies to foster productive collaborations and maximise efficiency
  • Strategies for effective communication with regulatory authorities
  • Exploring diverse aspects beyond clinical affairs in understanding MDR compliance
  • Highlighting successful examples of company-NB collaborations in the registration process

WORKSHOP: Soft skills, leadership strategies and project management excellence

  • Optimising processes, communication, and sponsor-CRO relationships in medical device development
  • Exploring the diverse skills and techniques required to manage multiple projects
  • Highlighting the significance of proactive project management in MDR implementation
  • Encouraging the improvement of communication practices in medical device development
  • Exploring methods to enhance collaboration, information sharing, and decision-making
  • Implementing strategies to optimise processes and achieve better project outcomes

Unravelling regulatory loopholes in clinical trials: understanding CE-based trials, purpose-based trials, and early feasibility studies

  • Defining regulatory loopholes and their significance in clinical trial operations
  • Navigating regulatory pathways for trials requiring CE compliance
  • Examining trials exempt from CE requirements and the associated implications
  • Exploring the intersection of academic funding and adherence to regulations
  • Highlighting regulatory provisions that can be advantageous for trial sponsors

Streamlining CRO selection, effective strategies and criteria for making informed choices

  • Exploring the impact of CRO selection on trial success and overall project outcomes
  • Identifying essential criteria for evaluating and comparing different CROs
  • Emphasising the importance of effective communication and collaboration with CRO partners
  • Utilising industry insights and feedback to validate CRO performance
  • Developing strategies to mitigate potential risks associated with CRO selection

Fostering positive CRO relationships: tips and best practice

  • Understanding the sponsor's role in driving successful collaborations with CROs
  • Identifying practices that foster productive and cooperative sponsor-CRO relationships
  • Mitigating sponsor-CRO Challenges
  • Addressing common challenges that sponsors pose to CROs during clinical trials
  • Strategies to balance expectations and optimise sponsor-CRO interaction

2024 Speakers

Select a speaker to learn more

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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:

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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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, 11:30 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
Analyst, Clinical Trials Intelligence, GlobalData

Sonnika Lamont, MRes, is a a Clinical Trials Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

Session Details:

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

2024-01-30, 2:45 PM

Session Details:

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

2024-01-31, 1:30 PM

View In Agenda
Next speaker
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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:

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

2024-01-30, 2:45 PM

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, 10:00 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.

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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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Next speaker
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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, 9:00 AM

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

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Anna Mayer
Lead Auditor, Non Active Medical Devices, TÜV SÜD

Session Details:

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

2024-01-30, 5:00 PM

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Next speaker
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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

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Sandra Kohler
Director, Clinical Operations, Xeltis

Session Details:

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

2024-01-30, 2:45 PM

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Yvonne Hoogeveen
Director, Clinical Affairs, Wellinq

Following attainment of a BSc in Biology at the University of Adelaide, Australia, I moved to the Netherlands to continue my education (Master degree and PhD). Started working in Medical Device industry (Cordis Europa NV, the Netherlands) in clinical research in 1991, participating in the multidisciplinary team developing and bringing to the market a hydrodynamic thrombectomy catheter for cardiology and peripheral applications (World-Wide, excl. USA), and permanent and temporary vena cava filters (World-wide including USA). Thereafter worked in academic research in interventional radiology (RadboudUMC Nijmegen) as well simultaneously continuing my work (from 2009 to current -Wellinq) in clinical research in device development projects (Urodynamic catheter & FFR catheter – combining catheter and sensor technology, peripheral angiography catheter and (DCB-)PTCA  devices). Following instigation of the MDR, the main focus was on achieving MDR certification for the marketed legacy devices. All reviewed dossiers were granted CE under MDR.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-01-31, 4:00 PM

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Enrico Perfler
Founder, 1Med

With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

Session Details:

Navigating 2024 MDR deadlines: a roadmap for medtech innovation

2024-01-30, 10:30 AM

Session Details:

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

2024-01-30, 2:45 PM

View In Agenda
Next speaker
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Pall Johannesson
Managing Director, Greenlight Guru

Session Details:

Key elements to outsourcing clinical activities in 2024

2024-01-30, 12:00 PM

View In Agenda
Next speaker
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Liam Spencer
Senior Regulatory Project Manager, Lumis International

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-01-31, 4:00 PM

View In Agenda
Next speaker
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Ben McConnochie
Director, Strategic Development, Acorn AI, Medidata

Session Details:

Linking clinical trial and real-world data: the future of medical device development

2024-01-30, 9:30 AM

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John Thomas
Director, Program Delivery, MedTech, Premier Research

John Thomas, MSc -  Director, Program Delivery MedTech. Based in the UK John brings over 20 years of industry knowledge within the CRO, pharmaceutical, biotech and medical device environments. John joined Premier Research as a senior CRA in 2008. Since then has leveraged his leadership skills to Clinical Management, Project Management, Senior Project Management and Associate Project Director. John is a proven leader, organizer, and director of all activities related to the execution of complex international clinical projects and small programs. Experienced in managing a wide range of medical device and pharmaceutical phases 1 - 3b clinical trials. John successfully delivered projects and managed sites on ASD closure devices, drug eluting cardiac stents, LAA closure devices, pacemakers, gastrointestinal medical devices, knee implants, septal closure devices for Patent Foramen Ovale, sham controlled devices for the treatment of diabetic foot ulcers, fecal incontinence studies and necrotizing enterocolitis in premature and low birth weight infants. John has a thorough background in researching a range of therapeutic areas in both medical devices and pharmacological compounds. By professional background, he has specialized in respiratory therapeutics but through his career, has also accumulated practical experience and theoretical knowledge of phase 1 CNS compounds, oral diabetic agents, and cardiovascular medicinal compounds. He has an excellent portfolio of testing techniques for a range of diseases and has academic accreditation to match his experiences.

 

Session Details:

The power of clinical data: what medical device developers need to know about MDR Article 61.4

2024-01-31, 9:30 AM

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Next speaker
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Wouter Mattheussens
Clinical Project Manager, QServe Group

Session Details:

Data management in clinical investigations: improving your study design and the quality of the data

2024-01-31, 10:30 AM

View In Agenda
Next speaker
Back
Antonio Li
Founder, easychinapprov

Session Details:

Learning from Chinese and US authority: comparisons and learnings for the EU

2024-01-31, 12:00 PM

View In Agenda
Next speaker
Back
Dr Cordula Stover
Senior Medical Writer, RQM+

Session Details:

Validated mobile health apps for health care improvement

2024-01-30, 4:30 PM

View In Agenda
Next speaker

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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