• 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

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

Sponsored by:

• 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

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

Speakers

Enrico Perfler

Founder, 1Med

Sponsored by:

• 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

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

Páll Jóhannesson

Executive Vice President, Greenlight Guru

Sponsored by:

• 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

• 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

• 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

Sponsored by:

• 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

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

• 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

• 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+

Sponsored by:

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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!

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

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