Outsourcing in Clinical Trials: Medical Devices Europe 2022
Hilton Munich Airport
5th-6th April, 2022
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Outsourcing in Clinical Trials: Medical Devices Europe 2022
At long last, Arena International is delighted to announce the return of the annual Outsourcing in Clinical Trials: Medical Devices Europe in Munich for 2022.
The 2022 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, 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 post-Covid.
The event will offer a safe and controlled space to finally enjoy the full in-person conference experience and collaborate with the biggest trial sponsors, manufacturers, and vendors from the continent and beyond. We look forward to seeing you there!
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.
175+
ATTENDEES
20+
EXHIBITORS
20+
SPEAKERS
82%
ATTENDEES AT DIRECTOR + LEVEL
Why Attend?
NETWORK
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This is an exceptional networking opportunity for industry accelerators from across the continent. Meet industry C-Suite and Director level executives to make valuable connection at this annual thought leadership platform.
LEARN
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Join like-minded peers to learn new perspectives and case studies through presentations, panel discussions, fireside chats, and interactive round tables.
ACTION
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The conference discusses the vital processes, solutions, and technology specific to the industry. Update your knowledge to create new strategies to better plan your operations and integrate new systems.

Benoît Marchal
Chief Digital Trust Officer,Partners for Patients
Biography: After 25+ years’ experience in the digitalization of clinical trials, the active participation of Benoît in the public-private consortium EHR4CR (Electronic Health Record for Clinical Research) has made him realize that there is a lot of value in all the data collected in the routine clinical setting and we should really maximize such usage in the best interest of medical research and thus the patients. Nevertheless, that is only achievable if we involve the patients in the most trustable, transparent and privacy respectful way. Through his participation to Partners for Patients, Benoît ambitions to promote the various approaches going in such a direction.
Session Details: Fireside Chat: Assessing the Flaws of the Medtech Industry and Considerations Needed to Improving the Clinical Trial Design 05-04-2022, 11:00 am On-Stage Interview: Considerations When Choosing a CRO for Your Study 05-04-2022, 12:00 pm Q&A with Expert Speaker: Assessing the Common Mistakes In IVDR Application Process 05-04-2022, 1:30 pm On-Stage Interview: Clinical Monitoring Considerations For Your Study 05-04-2022, 3:30 pm Fireside Chat: Considerations Needed Before Sourcing a Partner for a Clinical Study 05-04-2022, 4:00 pm View In Agenda

John Shillingford
Director of Clinical Research,Afon Technology Ltd (Formerly Orsus Medical)
Biography: 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: Chairman Opening Speech 06-04-2022, 8:20 am Fireside Chat: Preclinics – Biocompatibility of Medical Devices – Strategies and Pitfalls 06-04-2022, 1:15 pm Fireside Chat: Choosing the Right CMO For Your Study 06-04-2022, 3:15 pm View In Agenda

Brian Barnes
Senior Director, Product Development - Risk Based Quality Management & Digital Oversight,Medidata Solutions
Biography:
Session Details: Setting Up for Success: How MedTech Companies are Streamlining Operations with Risk-Based Strategies 05-04-2022, 9:00 am View In Agenda

Winfred Huesmann
Clinical Project Manager, BD
Biography:
Session Details: MDCG guidance 2021-06 from April 2021, Regulation (EU) 2017/745 06-04-2022, 8:30 am View In Agenda

Stefan Van der Meulen
AVP Global Clinical BD,NAMSA
Biography:
Based outside Ghent, Belgium, Stefaan Van der Meulen heads the Global Clinical Business Development team for NAMSA. Prior to this he was leading the Syntactx offices in Europe as a Managing Partner also overseeing business development for the company on a global scale.
Stefaan began his career in the pharmaceutical industry working on early- and late-phase clinical research studies of various sizes and indications. While working at Novartis, he was a global co-driver for their risk-based monitoring initiative, a best practice that is now being applied at Syntactx. At Cordis, a medical device developer and manufacturer, Stefaan concentrated on first-in-human and pivotal studies before transitioning to Core Laboratory and product specialist activities. He also has experience in product life-cycle development from both a clinical and marketing perspective.
Stefaan holds a Master of Biomedical Sciences from Ghent University in Belgium. He is fluent in Dutch, English, and French, and proficient in Italian and German.
Session Details: The Medical Device Regulation (2017/745) (MDR) in a Clinical Nutshell 05-04-2022, 10:00 am View In Agenda

Jana Meschede
Project Manager Clinical Affairs,Carl Zeiss Meditec AG
Biography:
Session Details: On-Stage Interview: Considerations When Choosing a CRO for Your Study 05-04-2022, 12:00 pm View In Agenda

Christoph Lindner
Team Leader Medical Device Testing,Tuv Sud
Biography:
Session Details: Fireside Chat: Preclinics – Biocompatibility of Medical Devices – Strategies and Pitfalls 06-04-2022, 1:15 pm View In Agenda

Herbert Mauch
Director Clinical Operations EMEA,Cochlear
Biography:
Session Details: On-Stage Interview: Clinical Monitoring Considerations For Your Study 05-04-2022, 3:30 pm Fireside Chat: Choosing the Right CMO For Your Study 06-04-2022, 3:15 pm View In Agenda

Dr. Christiana Hofmann
Teamlead non-active medical devices, Article 117 DACH & Nordics,TÜV SÜD
Biography: From my educational background I am biologist. I have completed my PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of toxicology. After that I gained several years of experience in the pharmaceutical industry with a focus on quality management. Since nearly 4 years, I am working within TÜV SÜD in the sector of Medical Health Services. Currently, I am leading a team of experts and auditors for non-active medical devices and I am responsible for the Article 117 business in the regions DACH & Nordics. Besides these roles, I am Auditor and Senior Product Specialist for non-active medical devices.
Session Details: The Future of Drug-Device Combinations Under The New Regulation MDR (May 2021) and the recently Updated Guidance Documents 05-04-2022, 9:30 am View In Agenda

Thomas Doerge
Global Head of Active Implantable Medical Devices,Regulatory Services, BSI
Biography: Thomas Doerge is the Global Head of Active Implantable Medical Devices at BSI and provides Medical Device expertise leadership and mentoring in areas of competence to the team. Prior to this position Thomas mentored and coached team members to deliver robust certificate decisions for Design dossier reviews as a Technical Team Manager. He has over 20 years’ experience in the Research and Development of AIMD products specifically in the field of neuromodulation.
Session Details: Lessons Learned from MDR Applications for Class III Devices 06-04-2022, 9:30 am View In Agenda

Floris Morang
Senior Account Executive,Castor
Biography: Floris is the global commercial lead for Medical Devices at Castor, a global eClinical solutions provider that supports drug and device manufacturers with data collection across the product lifecycle. Over the last 3.5 years, Floris has connected with over 300 medical device companies to help build solutions for their research and development needs. Floris' deep understanding and experience in medical device product development and clinical research helps him discuss these challenges and find solutions.
Session Details: Creating the Right Technology Ecosystem for your Clinical Trial 05-04-2022, 11:30 am View In Agenda

Dr Clemens Busse
Senior Client Manager, Regulatory Services,BSI
Biography: Dr Clemens Busse is currently working as a Senior Client Manager, Medical Devices at BSI, covering EMEA. He has worked in the IVD industry since 2009 in responsible functions for design and development and quality control. His tasks involved research activities, project planning and budgeting, development planning, data evaluation, raw material validation, performance and stability studies, and product troubleshooting. The product range he was responsible for during his career covers manual assays to fully automated solutions. He obtained an engineering degree in Biotechnology, followed by a PHD from the German Cancer Research Center in Heidelberg, Germany, in molecular virology.
Session Details: Performance Evaluation and Clinical Evidence under the IVDR 05-04-2022, 2:00 pm View In Agenda

Dr Andreas Stange
Vice President, Global Medical and Health Services,TÜV SÜD
Biography:
Session Details: Q&A with Expert Speaker: Assessing the Common Mistakes In IVDR Application Process 05-04-2022, 1:30 pm View In Agenda

Paul Swinckels
Chief Commercial Officer (CCO),LifeSense Group
Biography: Paul Swinckels is the Chief Commercial Officer (CCO) at LifeSense Group who has more than 20 years of experience in Electronic devices and since 2017 in the wearable medical devices technology. Paul knows how to bring added value to the customers and bring the needs into the right solution for the end user. Paul worked for 17 years in the high-end technology segment at GE in Western Europe which was acquired in by United Technologies later. With the experience of and partnering with private and government hospitals, clinics, Doctors and multi nationals, he provides the right solution for the real needs of the patients.
Session Details: View In Agenda

Ruth Pröbe
Director, Clinical Affairs EMEA,Cook Medical
Biography:
Session Details: Fireside Chat: Considerations Needed Before Sourcing a Partner for a Clinical Study 05-04-2022, 4:00 pm View In Agenda

Lucas Davy
CEO,Quinten Medical Device
Biography:
Session Details: Which Data Collection is Best Suited to your PMCF need? 06-04-2022, 11:15 am View In Agenda

Roland Kirchner
Director Research & Development,Leukocare
Biography:
Session Details: Codesign transfer: Ensuring Quality When Evaluating Designs Into Production 06-04-2022, 11:45 am View In Agenda

Laia Cass
Clinical Project Leader at Oxford Global Resources on behalf of Noucor ,Uriach
Biography:
Session Details: Fireside Chat: Assessing the Flaws of the Medtech Industry and Considerations Needed to Improving the Clinical Trial Design 05-04-2022, 11:00 am View In Agenda

Enrico Perfler
CEO & Founder ,1Med SA
Biography: 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: Top 5 Most Urgent Activities for MDR Compliance Before 2024 05-04-2022, 2:30 pm View In Agenda

Dr. med. habil. René Bombien
Cardiac Surgeon,TÜV SÜD Denmark
Biography:
Session Details: Clinical investigation requirements before CE marking and Post Market Clinical Follow Up (PMCF) 06-04-2022, 2:15 pm View In Agenda

Balint Feher
Senior Clinical Research Manager,Geistlich Pharma AG
Biography:
Session Details: Case study: Clinical digitalization success for medical device companies 06-04-2022, 10:45 am View In Agenda

Danish Mairaj
Senior Engineer, Software & Electronics,Vectura Group Plc.
Biography: Danish Mairaj is senior engineer at Vectura Group with over 10 years of experience in medical device industry in various roles including regulatory affairs. Vectura is a leading provider of innovative inhaled drug delivery solutions with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.
Session Details: Regulatory and Quality Strategy for Drug-Device Combination Product 06-04-2022, 1:45 pm View In Agenda

Joseph Zhou
CEO,Cardiosignal GmbH + Co., KG/ Xiongzhi Medical Technical Co., Ltd
Biography: My name is Joseph Zhou. I am the founder of Hongzhi Medical Device Technical Co., Ltd. I bought Cardiosignal GmbH in Dec 2018. Now we are applying for CFDA and CE for our latest Mechanical Heart Valve Monitor. We are doing research for our new device Heart Failure Monitor. What's more, we will doing research for Artificial Heart Monitor. All 3 household devices are very small and easily used. We focus on developing new cardiology household medical devices.
Session Details: View In Agenda

Heike Schön
Managing Director,Lumis International GmbH
Biography: Heike is the Shareholder and Co-Founder of Lumis International, Lumis Life Science Consulting and the newly founded UK branch Lumis International Limited. She has more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access. She is experienced in developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management and oversight management.
Session Details: View In Agenda

Wiebe Postma
Senior Consultant ,Qserve Group

Michelle Bulliard
Vice President,IQVIA MedTech Real World Solutions

Winfried Huesmann
Clinical Program Manager, BD





Quinten MD is a CRO with a unique solution for medical devices post-market activities.
Quinten MD helps its customers to harness the full potential of collecting 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.












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