Agenda

Donielle Johnson is Vice President, Regulatory Affairs Medical Devices for Bausch Health. In this role, Donielle leads the creation of a global medical device organization that supports strategic priorities ensuring access to innovative technology and compliant maintenance of business. She partners closely with stakeholders across Medical Devices and represents Bausch Health in various internal and external forums with regulatory bodies, health authorities, and trade associations. Donielle leads a dedicated team who work collaboratively to ensure consistency in global medical device policy shaping activities. Prior to Bausch Health, Donielle was the Sr. Director of Regulatory Affairs for EMEA & Canada at Johnson & Johnson. Prior to Johnson & Johnson, Donielle held several global roles with major medical device companies including Philips, Abbott Vascular, and Medtronic. Leading teams through challenging premarket approvals; such as, PMAs, 510(k), Health Canada approvals, and MDD Design Dossier approvals. Additionally, Donielle has extensive experience in lifecycle management and leading major manufacturing site change projects, resulting in several millions of annual savings for the company. Her career has spanned several countries including the U.S, Japan, and the Netherlands where she has lived since 2014.

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.

John joined Medtronic in September 2018 as Vice President, Regulatory Affairs & Quality EMEA. In May -19, he took on additional responsibility heading up Government Affairs EMEA. John brings nearly 30 years' experience from the healthcare sector, most recently in Brussels's European healthcare innovation and legislation policies. John was Secretary General for the European biotech trade association, EuropaBio, and Director of Regulatory Affairs and Industrial policy for nearly ten years at the European health industry trade association MedTech Europe. He also spent five years in the Medical Devices Unit within the European Commission. Before coming to Brussels, John worked in and managed the Irish Notified Body, NSAI, gaining extensive European and international experience in the design approval of high-risk devices and quality management systems. He sat on the working group which developed the international quality management systems standard for medical devices, ISO 13485. He began his career in the industry with five years' experience spanning the in vitro diagnostic, pharmaceutical and medical device industries. John is a science graduate from Dublin, Ireland, with added post-graduate studies in quality control and environmental engineering.

Matt is an Innovative leader with expertise in clinical operations, IVD development, and Companion Diagnostic development. He is a vibrant and perceptive professional skilled in building, repairing, and evolving critical partnerships, able to negotiate and build consensus with parties supporting strategic business goals. He has 25+ years’ experience in IVD and successfully executing extensive cohort clinical studies for submission to FDA, and BIMO Inspection management. He is a creative people leader dedicated to the growth and development of valuable and successful organizations with a proven track record of leading large groups of clinical affairs, data management, biostats, and project management personnel to expand capabilities and efficiencies while prioritizing team culture. Matt has an inclusive management style where communication is key to establishing trust and supporting top performance. At Illumina, he has created a center of excellence for clinical study execution by utilizing a process-oriented framework to managing clinical studies. At the core of the center of excellence is a strong team composed of uniquely qualified individuals with varying degrees of clinical operations expertise. His work has resulted in a Clinical Affairs department respected for its expertise and industry knowledge, one whose team members understand their roles, and, most importantly, who are excited and motivated to work together to improve human health by unlocking the power of the genome. Matt has a B.S. in Biology from the State University of New York at Binghamton, an M.S. in Molecular Biology and Immunology from Albany Medical College, and an M.B.A. in Finance from the University of Colorado at Denver. On the weekends and free time, Matt enjoys spending time with his husband, Steven, and their Vizsla, Jaxon. He enjoys cooking, eating great foods, and drinking wines and tequila. When not trying new restaurants in San Francisco, he loves traveling and laying on the beach in Oahu.

With eighteen years in clinical research, Kellie Hazell has supported, monitored and managed pulmonary devices, oncology pharma, and in vitro diagnostics studies. Kellie has been with Illumina for three years and manages Illumina's Veeva platform for the Medical organization, focusing on ClinOps and CDMS.

Melissa is an experienced regulatory and quality professional with more than 20 years of experience in in-vitro diagnostics. Before joining SOPHiA Genetics as the Chief Regulatory Officer in May 2021, she worked for bioMérieux where she held various positions in product development, project management, complaint handling, labeling, and quality. Having lived and worked in multiple countries, she has experienced first-hand the challenges of cross-cultural communication and international management on a global scale and is passionate about the role of quality in facilitating efficient operations.

Tom is the head of Clinical and MedTech Knowledge Management and Quality Systems at SOPHiA GENETICS. He has more than 20 years of experience in academic, clinical, and industry settings leading Business Transformation, Quality Assurance, and Global Training initiatives. He has a diverse portfolio of scientific and IP achievements in Structural Biology, Data Science, Virus Genomics, and Cancer. He is a seasoned computational biologist with substantial training in molecular, clinical, and computer sciences.

Kazuhisa joined Terumo Corporation in 1987 as a research engineer and was involved in medical device development projects such as a drug-eluting stent, Nobori®/Ultimaster®. From 2009 to 2015, he worked in Terumo Europe, in Belgium as a clinical scientific manager to generate clinical evidence for the purpose of regulatory approval in EU and outside EU. In 2017, Kazuhisa assumed Chief clinical & regulatory affairs officer in Tokyo, Japan.

Passionate lobbyist and responsible for the entire area of Regulatory Affairs & Quality for the Association of the IVD Industry in Germany (VDGH). In addition to various co-chairmanships in the European association MedTech Europe (MTE), he is very well connected in German politics and authorities and the EU Parliament, the Council, and the EU Commission. Dr. Sascha Wettmarshausen is also professionally involved in various advisory boards (Rili-BÄK - German Medical Association), NAMed (DIN), Entourage (management consultancy) and others from the heart.

ConvaTec is a Medical Device company specialising in medical devices for wound care, continence care, critical care, ostomy care and infusion care. Julie is a member of ConvaTec's Medical and Clinical Affairs Group based in the UK and is responsible for all of the clinical studies conducted by ConvaTec involving human subjects.

With more than 20 years of experience in the healthcare arena, from pharma to medical devices (6 years) and surgery facility management, Michele put Digital Transformation as the pillar of his actions to increase profitability and productivity from a strategic and tactical standpoint. Michele specialises in CRM, ERP, and system integration via ETL platforms.

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.