Agenda

Sarah Johnson, Ph.D., VP, Head of Clinical Affairs for QIAGEN, leads a team of clinical specialists to deliver global multi-site clinical studies on MDx and CDx products. As an expert in clinical affairs, diagnostics, and women’s reproductive health, she has >40 peer-reviewed publications in the diagnostics field. Previously she has headed up regulatory affairs, medical affairs, and research in other diagnostic companies, also holding the role of UK company director and site lead for SPD Swiss Precision Diagnostics development co. She has a Ph.D. in cell biology and was a qualified medical geneticist.

Pernille Troejgaard has a Master’s in pharmacy from the University of Copenhagen and has worked with Medical Device clinical trials for +20 years. Pernille has had different roles within clinical research, including project management and clinical strategy development, currently heading up the Clinical Operations team at Coloplast A/S, being responsible for all clinical trials within Ostomy, Continence and Wound Care.

Kelly Gee has a diverse background, including education, enforcement, and regulatory affairs. Currently, she is involved in QA support for various in-house projects centered around Software used to support/control processes involved in manufacturing medical devices, including Quality Management, Warehouse Management, and other Enterprise Business suite (Oracle EBs) systems. Kelly recently co-led Veeva’s RIM (Regulatory Information Management) software implementation.

In 1990, Holger Schmidt graduated from TU Darmstadt with a degree in Electrical Engineering and Business Administration. That same year, he began his professional career at Siemens as a consultant for R&D in Munich, Germany. Four years later, he transferred to Siemens Healthineers. He initially worked in product management, process re-engineering, and regulatory compliance. Holger Schmidt gained management experience in Supply Chain Management at Magnetic Resonance, Customer Relationship Management at Picture Archiving and Communication System (PACS), head of PACS, Special Products, Oncology Care Systems in Concord, California, and head of Particle Therapy. In September 2013, he was appointed Head of Quality for Siemens Healthineers.

Focus on the customer experience within the scientific and medical market space. Multiple positions in Germany and the US in sales, marketing, and communication in ZEISS Microscopy and Medical technology segment. Building understanding to adapt Marketing technology to special requirements of a regulated market and in the moment driving the transformation to data-driven, platform-based engagement to create a differentiating digital customer experience.

Dr. Doris Röthlein graduated as a biochemist at the university Bayreuth, Germany, and was awarded her Ph.D. at the Free University in Berlin. Since 2001 she has been working in various functions at B. Braun in different areas of Medical Affairs and R&D. Over the years, she acquired broad expertise in project management, cooperation management, and product development of both medical devices and pharmaceuticals. In her current function as Vice President Clinical Development, she is responsible for the management of clinical studies and the global clinical study strategy of the B. Braun division of Hospital Care.

Dr. Bernhard Glotzbach graduated as a biologist at the Technical University of Darmstadt, Germany, and was awarded with his Ph.D. in biochemistry at the same university. Since 2013 he has been working as Scientific Manager at B. Braun at the Medical Scientific Affairs department of the Hospital Care Division. Over the years, he acquired broad expertise in project administration and management of clinical studies with both medical devices and pharmaceuticals. In his current function as Senior Scientific Manager, he is, additionally to study management tasks, responsible for the overall project management of the global Clinical Trials Management System at B. Braun (B.Trials).

Erik specialises in EU and national legal and regulatory issues relating to medical devices, IVDs, medicines and biotechnology, with a focus on legal and regulatory advice, contracts, regulatory litigation against competent authorities and M&A. Erik is the author of the acclaimed Medicadeviceslegal.com blog and The Enriched MDR and IVDR handbook.

Jesús heads the International Affairs team. He is involved in the work at the international level acting as representative to WHO, ISO and as liaison to other associations on all regulatory matters.

Directly involved in the discussions on the revision and recast of the IVD Directive, he previously lead the regulatory debates that affect IVDs at EU level until 2016.

A Spanish national with a biochemistry background, he is also fluent in English and French.

Hayden Atkinson has a background in systems engineering and has been with CooperVision for 23 years, working in several different departments, from R&D to Regulatory and Quality. He is currently responsible for the compliance of all the global systems CooperVision utilizes.

Daniel is Vice President of Marketing and has been leading the marketing transformation for Philips Health since February 2023. This includes the restructuring and implementation of a new org design across businesses, markets, and functions. He served as Vice President of Marketing for Philips Image Guide Therapy business group from 2018 – 2022 and was Vice President of Strategy and Marketing for Image Guided Therapy Systems business from 2015-2018. He has set up and led multiple business ventures as well as numerous marketing teams on three continents over he’s career and has a passion for driving change and challenging the status quo.

Jessica Pavic is project manager, digital transformation at Fresenius Medical Care where she is leading the global implementation of Vault PromoMats. Her interests revolve around digital transformation and marketing technologies.

Lois Spencer is a highly driven, dedicated professional with 15+ years’ experience in the IT field, with a background in Portfolio Management Office (PMO). Possessing strong interpersonal, communication, and organizational abilities. Strong in collaborating with senior leadership, peers, and user communities to constantly drive process improvement. Recognized as a creative thinker with strong analytical skills, adept at conceptualizing solutions that align to objectives within acceptable level of risk. Skilled in business process improvement, ITIL, program, and project management.

Dr. Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business. He spent the last year consulting and supporting medical device, in-vitro diagnostic, and combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in drafting several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Dr. Fatima Bennai-Sanfourche is Global Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG where she is focused on ensuring compliance and high product quality, as well as compliant use of medical devices and software tools for clinical investigations and trials. She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) and is a member of the European Commission Post-Market Surveillance (PMS) task force.

Andreas has 20+ years of international leadership experience in various roles and industries. He build his own startup in the area of Information Management and has experiences in merger & acquisitions both on the selling side and the acquiring side of the business. During his 13 years career at Roche he held various leadership positions in Affiliates, the Region EMEA/LATAM and took the global responsibility for a core IVD portfolio. While leading the global Marketing team of Roche Diagnostics Core Laboratory Business Area, he managed Covid-19 pandemic Data Science Task forces, led transformational organisational design sprints and eventually took over the lead of global Digital Marketing lead in July 2021. Andreas passed an education on AI and Machine Learning for Business Leaders at the MIT Sloan Institut in Boston, US.

Marie-Pierre Dewez is Clinical Operations Director at Europe Medical and Clinical Division, Terumo Europe. Terumo is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for nearly 100 years (HQ based in Tokyo). Its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Marie-Pierre has over 25 years of clinical research experience in medical device and pharmaceutical industries holding different clinical positions at Bristol-Myers Squibb, Cordis, Boston Scientific and Volcano/Philips. Marie-Pierre joined Terumo five year ago and is currently managing the Clinical Operations group, based in Belgium. She is driven by operational efficiency, patient care, talented and dedicated team and by Terumo’s Core Values.

Biologist as background with a master's in marine biology. With 14 years of clinical experience in the medical device industry and holding different positions within the Terumo organization, I am currently a Clinical Operations Manager. In this role, I ensure proper planning and execution of the entire clinical trial portfolio at Terumo Europe. Additionally, I coordinate within the Terumo corporation team a global initiative bringing the different Terumo companies together to support the harmonization of the clinical operations groups. My drivers are efficiency, team spirit, and quality, considering the patient's well-being.

Tobias is Director Regulatory Affairs' in Siemens Healthineers' corporate quality governance function, working with his team on international regulatory policies and requirements. With over 20 years of experience in the MedTech sector, he has over 8 years of leadership experience in strategic and operative quality- and regulatory affairs management. In addition, leads the Siemens Healthineers' regulatory intelligence programme. Tobias has a background as radiographer, IT and is a trained EMT. He is coaching startups via MedTech Bootcamp and lectures at the Friedrich Maximillian University of Erlangen-Nuremberg.

Marianne Wrang is a Senior Business Application Specialist at Coloplast in the headquarters in Humlebæk, Denmark. Coloplast develops products and services that make life easier for people with personal and private medical conditions. Its business includes Ostomy Care, Continence Care, Wound and Skin Care, Interventional Urology, and Voice & Respiratory Care. Coloplast operates globally, and the organization has about 14,500 employees. Marianne has over 20 years of experience with application management within the medical device and pharmaceutical industries. She is part of the core team behind the Veeva journey in Coloplast. She is the Program Manager of the ‘Veeva Suite Program’ implementing Veeva QualityDocs, Veeva QMS, Veeva eTMF and Veeva CTMS. She is driven by operational efficiency, focusing on user experience and reducing non-value-adding time spent in the system for the users.

Dr. Davide Manissero is Chief Medical Officer at QIAGEN. He joined the industry after training in pediatrics and tropical medicine and working in global public health for WHO and ECDC. His industry experience includes the development and introduction of novel antibiotics and ID diagnostics extending to both molecular and immunodiagnostics. His academic interest extends to infectious diseases, antibiotic development, and the understanding of antimicrobial resistance. Physician, pharma, and IVD medical expert, he's developing disease solutions and bringing them closer to the patient.

Andreas has 20+ years of international leadership experience in various roles and industries. He build his own startup in the area of Information Management and has experiences in merger & acquisitions both on the selling side and the acquiring side of the business. During his 13 years career at Roche he held various leadership positions in Affiliates, the Region EMEA/LATAM and took the global responsibility for a core IVD portfolio. While leading the global Marketing team of Roche Diagnostics Core Laboratory Business Area, he managed Covid-19 pandemic Data Science Task forces, led transformational organisational design sprints and eventually took over the lead of global Digital Marketing lead in July 2021. Andreas passed an education on AI and Machine Learning for Business Leaders at the MIT Sloan Institut in Boston, US.

Lia Parker is a QMS Training Expert with a proven track record in Quality Assurance and extensive teaching experience, driving compliance within the IVD/Medical Device Manufacturing industry. In addition, Lia has more than eight years' of experience designing and delivering comprehensive learning programs. Lia has extensive knowledge of ISO 13485 and MDSAP regulations and is adept at aligning training content with industry standards and regulatory requirements.

Adetola Odufuwa is an experienced QA Manager with eight years of expertise in IVD/Medical Device Manufacturing and five years in Quality Assurance. Adetola leads and motivates a team of 30+ professionals across 4 Quality functions (including QMS Training) within The Binding Site, Part of Thermo Fisher Scientific. Certified internal auditor for ISO 13485:2016, MDSAP, EU IVDR 2017/746, and ISO 14001:2015. Chartered Quality Institute Practitioner (PCQI) with a comprehensive skill set encompassing risk management, root cause analysis, project management, regulatory compliance, GMP, and more. Adetola is a strong proponent of learning & development to facilitate continuous improvement and assurance of product quality and safety in highly regulated environments.

Dr. Carlo Messina is a Global Medical Affairs Leader. He previously served as the Head of Global Medical Affairs ctDx Oncology at Agilent Technologies, and Roche Diagnostics as Global Senior Director for Oncology in Clinical Development and Medical Affairs.

Carlo is a board-certified medical oncologist in Italy and has also worked as a clinical research physician at the European Organization and Treatment of Cancer. He has actively participated in genito-urinary cancer clinical trials and treated patients with solid tumors as a medical oncologist at San Camillo and Forlanini Hospitals in Rome.

In her current role as Director, Global Clinical Operations at QIAGEN, Kirsty is responsible for the supporting functions that ensure the smooth running of molecular and companion diagnostics studies at QIAGEN. Her team is responsible for clinical trial administration and monitoring, data management, finance and project management, biospecimen management, and logistics, and overseeing compliance to procedures, standards, and regulations. Before joining QIAGEN, Kirsty was Director of Clinical Operations for Johnson and Johnson and has over 25 years of experience in the In-Vitro Diagnostics industry-leading clinical research supporting the delivery of many new technologies. She was responsible for the conduct of multiple studies for various stakeholders relating to determining product feasibility, global product registration, claims assessment, outcomes, and post-market surveillance. Kirsty holds a BSc in Applied Biomedical Science from Glasgow Caledonian University.

Jay is currently VP of Medical Device Solutions and Services at USDM Life Sciences. Prior to joining the firm in 2014, he was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.

Oliver joined MedTech Europe in 2017, originally heading the department which supports members in implementing new and changing EU regulatory requirements affecting the medical technology industry. In January 2023, Oliver assumed the role of Chief Executive Officer, responsible for the association’s overall management and strategy and reporting to the Board of Directors.

Oliver’s passion is to see the value of medical technology innovation fully recognised as a source of solutions to the many challenges facing healthcare systems, economies and societies, both in Europe and around the world.

Prior to joining MedTech Europe, he worked at Medtronic as Director of Regulatory Policy for EMEA. In addition to this company experience, Oliver had various trade association roles in Brussels, at COCIR (the European association for the radiological, electromedical and healthcare IT industries) and at EDANA (the industry association for the nonwovens and related industries).

Oliver is a native speaker of English, and a dual national of Australia and Malta.

When not working, he enjoys travel, spending time with his family, and rock-climbing.

PETER SCHROEER is the EMEAC Regional Vice President for Regulatory Affairs at Johnson & Johnson MedTech. Prior to joining Johnson & Johnson, Peter began his career in the chemical industry. In the Medical Devices industry, he set up manufacturing and servicing structures for active and passive medical devices, lead Quality System and Product certification programs according to international standards, national and EU Medical Device regulations. He is the Vice Chair of the MedTech Europe Regulatory Affairs Council, a member of the R&I Committee, and an active member of several working groups.