Ruth Foster is a Member of the 2021 Medtech & Pharma Program Committee. She studied Chemistry in the UK and has worked in the medical industry for over 35 years. She started out in in vitro diagnostics (IVDs), followed by pharmaceuticals, then 14 years with a Medical Device company and now she has been working with MSD for just over 4 years in the area of Drug Device Combination products, Digital Health Solutions and Companion Diagnostics. She chaired the Blood Safety Group at Eucomed (now MedTech Europe) when she worked for the Medical Device company and she is now the EFPIA representative to the European Commission’s Medical Device Coordination Group (MDCG) New Technologies and Software sub-group.

Mike is Global Head RA Medical Devices, Combination Products & Precision Medicine at Novartis Pharma AG since August 2022. In this role, Mike oversees all regulatory activities related to Medical Devices & Combination Products and Precision Medicine at Novartis globally. Prior to this role Mike was managing the EU MDR implementation at Novartis. Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit, and developed further into a role as Executive Director in QA, overseeing all compliance activities related to Medical Devices & Combination Products at Novartis. Before joining Novartis, he was Director Global Audit Systems at Gambro Renal Care (today Baxter), and European Head Quality Systems & Audits at 3M. Mike is a member of several US and EU Expert Committees and Interest Groups on Combination Products, and lecturer at the Universities in Baltimore (US) and Bern (CH) on Medical Devices & Combination Products. Mike studied Chemical Engineering and Plastic Technologies in Münster, Germany, and has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.

Nathalie is a Member of the 2023 Medtech & Pharma Program Committee. In her role as Senior Director Public Affairs and Regulatory Intelligence at SFL Regulatory Affairs & Scientific Communication GmbH, she provides strategic policy and regulatory intelligence support to interdisciplinary projects for a wide range of products in the life sciences field such as in vitro diagnostics.

With her expertise in law and policy making processes in Switzerland and the European Union, she plays a crucial role in the engagement and organizational work of national and international associations. With a main interest in innovative product development and through regular interaction with stakeholders from academia, industry and patient groups, she has insights into different perspectives on current health policy topics including digital health. Nathalie holds an MD from the Medical University of Vienna, Austria, and a Master of Laws degree in Medical Law with emphasis on the legal framework for Advanced Therapy Medicinal Products.

Marisa Papaluca Amati, MD, graduated in 1978 at the State University ‘la Sapienza’ in Rome – Italy with a research focus on clinical immunology. She specialized in internal medicine and continued clinical work till 1994. Marisa joined the Pharmaceuticals department of the Italian Ministry of Health and in 1990 established the first Office for Centralized Community Procedures (OCCP), focusing on the regulatory evaluation of r-h-DNA medicines at European and international level. In 1994, Marisa moved to London and was thefirst recruited scientist at the EMA: she pioneered the new EU medicines system, pursuing the integration of innovation in medicines and leading regulatory science initiatives in genomics, cell and gene therapy, biomarkers, nanotechnology, personalized medicine, innovative clinical trials designs, pharmaceuticals and devices combination products. On these themes Marisa created and led safe harbors such as the EMA Innovation Task Force and the Business Pipeline service and established the EMA specialized scientific support office. Appointed as the first EMA Senior Scientific Advisor, she played a key role in establishing the EU Innovation offices Network across Member States, the pilot EMA Regulatory Science Observatory and the EMA Regulatory Science Strategy to 2025. Marisa published extensively on relevant themes with chapters in books and articles in peer reviewed scientific journals. She has been also panelist, speaker and chair in EU and international conferences, workshops and seminars. Lecturer since 2008 in the faculty of medicines of the Tor Vergata University in Rome, she was awarded in 2016 the status of Emeritus Professor. In 2019, Marisa joined the Public Health and Primary Care department at Imperial College London, and is an invited expert at WHO (science division) and European Commission (Research and Innovation Directorate).

Christiana Hofmann works at Anteris by Kymanox and she is a medical device and combination product senior professional with more than 10 years experience in the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. Christiana’s main focus and experience as SME is Art 117 MDR. Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region.

Marie-Claire Beurier is a Regulatory Group Director at F. Hoffmann-La Roche Ltd, Basel. She graduated as an engineer in analytical chemistry in France. In 1998, she started her professional career in analytical development in the veterinary industry in the Netherlands at Intervet (now MSD Animal Health). Then she moved to France and continued to develop in analytical and CMC activities as a technical regulatory lead. In 2002, she joined Roche Basel and worked in regulatory affairs as Country Manager for the Middle East. She further developed into a DRA manager role for mature products for several years , then as an EU partner in oncology drug development and for another 9 years as Global Regulatory Lead. Her areas of expertise are in oncology lung and tumor agnostic which are disease areas involved with many biomarkers and companion diagnostics. Particularly, Marie-Claire was the GRL for the new molecule entrectinib (trade name Rozlytrek) targeting NTRK and ROS biomarkers. For the last 2 years, Marie-Claire moved into line management of EU oncology program managers and is also involved with regulatory infrastructure activities. In this context, Marie-Claire has been heavily involved with the implementation of IVDR at Roche.