Marius oversees clinical studies and evaluations for a major segment of Aesculap’s (a B. Braun division) product line. A key department contributor since 2016, his expertise spans clinical research, project management, and cross-divisional collaboration. Marius holds a degree in Clinical Research from the University for Continuing Education Krems.

Kasper helps life science companies navigate organizational transformation through AI-driven omnichannel strategies. He previously spent over 20 years in leadership roles at Novo Nordisk, LEO Pharma, and Ferring, pioneering digital marketing innovations. A global connector, Kasper brings an international perspective to every challenge, focusing on marketing strategy and change management.

Jay is a technology leader in the life science industry with experience driving enterprise digital transformation programs. He is responsible for a technology team that manages medical, regulatory, and AI products at Baxter, and he’s passionate about bridging the gap between AI potential and real work impact. Jay focuses on strategies that enhance operational efficiency, improve decision-making, and unlock new opportunities while ensuring safe and responsible use of AI.

David brings over 15 years of experience in global quality and regulatory leadership. He excels at enhancing customer satisfaction, operational efficiency, and international compliance. David’s expertise includes building high-performing global teams, developing quality management systems, and resolving complex regulatory challenges. He hold deep knowledge of FDA 820, ISO 13485, MDR, MDSAP, and IVDR, combining a global perspective with a proven track record in optimizing quality operations.

As the regulatory affairs lifecycle management team lead at bioMérieux, Marie-Pierre and her team are responsible for ensuring global regulatory compliance for IVD products throughout their lifecycle. With over 20 years at bioMérieux, including a decade implementing new modules in the company’s quality tool, she also serves as the business process owner for their new Veeva RIM solution.

Drawing on a strong background in quality systems engineering and IT product ownership, Olivia is uniquely equipped to drive business transformation at Boston Scientific. She effectively combines operational excellence and systems thinking with agile leadership to achieve her goals.

Jayanth is responsible for the regulatory oversight of medical devices and for developing wider BSI strategy and policies. With over a decade at BSI, where he previously held senior roles, including Head of the UK approved body, Jayanth also serves as chair of the Notified Body Technical Group (NBTG) for medical devices. Prior to joining BSI, he was a chief scientist at a medical device startup. Jayanth holds a PhD in bioengineering from the University of Leeds.

Venkiteshwar brings over 15 years of expertise in global medical device regulations, including FDA, GCPs, and ICH guidelines, as well as clinical study lifecycle management.

Herbert leads clinical trial execution in EMEA, focusing on operational excellence and data integration. He has championed the unification of Veeva eTMF, CTMS, and EDC to drive compliance and transparency, and leverages Veeva Clinical Data to enhance trial performance.

Benjamin has more than 17 years experience in the medical device industry. Since joining Coloplast in 2020, he’s ensured that the regulatory affairs (RA) function efficiently supports the company’s innovation and growth. He leads RA to drive timely market entry for new products, sustained lifecycle management, and compliance with global regulations. Benjamin has held RA roles in start-ups, SMEs, and multinational companies, working on projects across a wide array of medical specialties and healthcare technologies. He also teaches at the university level aiming to inspire future RA professionals.

With over 14 years of experience in the pharmaceutical industry, specialising in regulatory affairs for global markets, Anna has a proven track record in handling marketing authorisation applications (MMAs) and leading cross-functional teams. Her expertise spans chemistry, manufacturing, and controls (CMC) lifecycle maintenance, post-approval changes, and navigating complex global regulatory landscapes.

With a career spanning over 25 years in the medical device industry, Amanda has a strong background in scientific support, customer training, and regulatory processes. In her capacity as a subject matter expert, she collaborates with cross-functional teams on critical initiatives such as new product development and change control. Her notable achievements include leading a notified body transfer, implementing the EU MDR, and deploying Veeva Submissions and Submissions Archive.

With over 25 years in the optical industry and 15 years as an optometrist, Dimple brings deep expertise to advancing eye care. A respected speaker at UK and Ireland conferences since 2011, she has championed in-practice education and training to improve practitioner skills and patient outcomes. Her extensive clinical experience and strategic industry insight make her a trusted leader in professional development and innovation within optometry.

Derrick has over a decade of experience in content supply chain strategy and marketing technology. He also has expertise in creating comprehensive content lifecycle strategies to increase speed to market in an ever-changing environment. At Fresenius Medical Care, Derrick is dedicated to streamlining internal operations and driving adoption of marketing technology.

Milind leads medical governance and digital health at Fresenius Medical Care. He specializes in vascular access and using digital health, including AI, to improve dialysis care. A gold medalist in medicine, he completed his postgraduate training in the UK and established one of Singapore’s first interventional nephrology programs.

Mireille champions innovation in risk-based quality management (RBQM) for diagnostic clinical trials at GE Healthcare. With over 30 years in clinical research, she led global pharma and CRO teams. A founding contributor to TransCelerate’s RBM initiative and co-developer of the original risk assesment and categorization tool (RACT), Mireille shaped industry standards and drove RBQM adoption.

As IVDR/IVD international manager at GMED, Tom oversees notified body (NB) responsibilities, client engagement, and international site collaboration. He also serves as secretary of the NBCG-Med executive committee. Tom brings over five years of NB experience, including head of NB roles, and more than 12 years in the IVD industry.

Laure-Anne Thieren is a Business Process Quality Director at Johnson & Johnson, where she has over 18 years of experience in quality and compliance. She is a key contributor to the EU MDR and Eudamed implementation projects for J&J’s MedTech organization and a respected voice in the industry, co-chairing the MedTech Europe PMS working group and advising the European Commission on vigilance and Post-Market Surveillance (PMS).

Christian is a seasoned quality professional with over 15 years of experience, including 5+ years in manufacturing operations. A recognized subject matter expert in risk management (ICH Q9/ISO 14971), he brings deep knowledge of global current good manufacturing practices (cGMP), as well as pharmaceutical and medical legislation across EU, FDA, and Japan. Christian has a proven track record of establishing robust, quality-driven operations across international sites.

Elizabeth is the Corporate Director of Regulatory Affairs at MED-EL, a global innovation leader in hearing loss solutions. Since joining the company in 2006, she has led the corporate regulatory affairs function with global responsibility for product licensing, registrations, and regulatory strategies for new product developments in more than 140 markets. Her background includes prior experience in regulatory compliance at Vodafone Ireland and a social sciences degree from the University of the Witwatersrand, where she was also a long-time lecturer and social researcher.

Ashley has served as Novocure’s CEO since January 2025. Prior to becoming CEO, she was the company’s CFO. She has been integral to building Novocure’s global organization and positioning the company for each stage of its growth. Before Novocure, her experience included various financial roles at Zoetis and Pfizer.

Dedicated to patient safety and quality by design, Robby specializes in enhancing end-to-end design quality engineering. He leads strategic initiatives that leverage advanced quality monitoring and data analytics to deliver safer, more effective medical solutions. His commitment is to collaborative improvement, with the ultimate goal of achieving better patient outcomes.

With nearly 20 years of experience in multinational corporations, Michael has a proven track record as a people leader in both technical and management roles across regulatory, R&D, innovation, and project management. His focus is on building high-performing, cross-functional teams within complex organizations by combining strategic and technical expertise.

With nearly 30 years of experience in the in-vitro diagnostics industry, Kirsty has led clinical research for product feasibility, global registration, and post-market surveillance. She was previously the director of clinical operations for Johnson & Johnson and holds a BSc in applied biomedical science from Glasgow Caledonian University.

With over 25 years of experience, Christian is a seasoned leader in infectious diseases and diagnostics. He focuses on translating innovative science into tangible healthcare actions for patients. His background includes a doctorate in virology and experience in both assay development and immunotherapies.

After graduating with a masters in AI and machine learning from Imperial College, James worked as a data scientist before co-founding Scarlet with Jamie Cox to hasten the transition to universally accessible and affordable healthcare. He has spent nearly four years developing Scarlet into Europe’s only software and AI-specialized notified body, which certifies medical software under MDR more efficiently and frequently than ever before.

Holger began his career as an R&D consultant at Siemens and moved to Siemens Healthineers four years later, focusing initially on product management, process re-engineering, and regulatory compliance. He then took on significant leadership roles in supply chain management, customer relationship management for picture archiving and communication system (PACS), and ultimately served as head of PACS, special products, oncology care systems, and head of particle therapy. In September 2013, he was appointed head of quality for Siemens Healthineers.

Kolja Boese, MD, PhD is currently the head of global medical affairs at Smith+Nephew, bringing an extensive clinical research experience in the medical device industry. A board-certified orthopedic surgeon and senior lecturer, he has broad clinical expertise at the university level and a substantial publication record with over 60 internationally peer-reviewed papers.

Dian leads clinical evaluations for Sonova’s hearing devices, bringing over a decade of expertise in medical device clinical affairs. She specializes in generating, optimizing, and leveraging clinical data to ensure device safety and performance, consistently improving research quality and efficiency.

With over 24 years of experience in the pharmaceutical and medical device industries, Sébastien has led global R&D, medical affairs, and brand teams across therapeutic areas including oncology, cardiology, and CNS, as well as diagnostic and interventional radiology.
His expertise covers clinical development and medical affairs strategy, and he leads strategic partnerships with key opinion leaders and medical societies to drive global innovation. Sébastien is particularly interested in how AI can transform and enhance medical affairs capabilities.

With 18 years of experience in clinical research and data management, Elson holds a master of public health and brings expertise in medical device, EDC systems, CDISC standards, and regulatory compliance. His strong background in life sciences and public health fuels his commitment to data integrity, patient safety, and a passion for improving health outcomes through high-quality data.

With more than 20 years of experience in data management, clinical research, project management, and product management, John has a steadfast commitment to optimizing processes to enable compliant, end-to-end clinical trial execution and evidence generation. He holds an MBA and MPH, and has served in leadership roles in medtech and biopharma prior to joining Veeva MedTech.

Drawing on her background as a consultant, Arielle specializes in the European medtech market. She helps companies transform quality and regulatory (QARA) from a compliance exercise into a value-adding function that increases efficiency and accelerates speed to market.

With over 18 years of clinical research experience in the medical device and pharmaceutical industries, Stéphanie has held various clinical positions at ClinResearch (now ICON) and Sirtex. Her background includes a focus on project management and clinical strategy development. Stéphanie holds a master’s degree in nutritional sciences from the University of Bonn and the University of Toronto.

Ramona holds a PhD in molecular and cellular biology and has a strong background in regulatory affairs. She is an expert focused on helping the medtech industry navigate its unique challenges, particularly those arising from a continuously changing regulatory environment, by using best practices and a defined framework.

Diogo has extensive experience in regulatory affairs and orthopaedic implants, having served as a UKCA certification manager at DNV and a designer at Stryker/Stanmore Implants. He holds a PhD in biomechanics from Imperial College London, where he also patented a novel glenoid implant. He combines academic rigor with hands-on experience in orthopaedic design and regulatory affairs.

Chris is a seasoned executive with over 20 years of experience in the life sciences industry. As a former VP at Johnson & Johnson, he has a proven track record of driving global digital business transformation and specializes in concept-to-launch AI digital product strategies. An industry thought leader, Chris holds an MBA from Cornell University, where he also guest lectures on digital strategy.

With over 15 years of experience in the medtech industry, Annemien has a deep understanding of end-to-end device development and digital transformation across clinical, regulatory, quality, and commercial functions. She holds a PhD in interorganizational collaboration in medical product development.

With over 23 years of experience in the healthcare industry, Amra has spent the majority of her career in a variety of regulatory roles at large medical device companies, including Abbott, Bayer, and Medtronic. She has extensive expertise in global regulatory advocacy, strategy, and intelligence, having represented organizations in numerous external workig groups. Amra is also engaged in teaching international regulatory affairs at St. Cloud State University.

Frank brings a unique dual perspective from his career on both sides of the medtech industry. He began by developing orthopedic implants before founding and successfully exiting a startup that simplified the conduct clinical trials using software and AI-based medical image analysis. His expertise lies at the intersection of medical technology, clinical data, and software innovation.

Pearl has a strong background in medicine, research, and business strategy, with a focus on digital transformation in the European medtech sector. She has intensive experience optimizing content strategies to drive compliance, efficiency, and innovation. Her career includes leadership roles at Philips, where she spearheaded clinical marketing strategies across multiple portfolios. Pearl holds both an MD and an MBA.