MedDev Day - Relatori

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, 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 the 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 the drafting of 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.

Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

Daniel Delfosse, Dr.sc.techn., is Vice-Director and Head of Regulation & Innovation at the industry association Swiss Medtech. His mantra is “innovation despite regulation” and he pursues the goal of keeping Switzerland an attractive location for the medtech industry.
Daniel graduated from ETH Zurich as a materials engineer and did his doctorate at EPF Lausanne. After a research stay at the University of British Columbia in Vancouver, Canada, he moved to the medtech industry. For almost 20 years he worked as head of development and member of the executive board for a Swiss orthopaedics company, always at the crossroads between regulation and innovation

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs of MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria.
Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function which has global responsibility for product licensing, registrations, re-certifications, post-market vigilance activities, regulatory strategies for new product developments and related compliance activities internally within MED-EL and externally to new and changed regulations and standards.

William Lory, Pharm. D. is Regulatory Affairs Manager EMEA at Sirtex Medical whose mission is to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 10+ years of experience in medical device regulatory affairs with multiple submissions at global scale and more specifically according to the Medical Device Regulation (EU) 2017/745.

Glenda Marsh is a corporate executive with over 20 years of global experience in regulatory affairs, program management and operations across the health-care industry, including medical devices, biotech and consumer products.

Since joining Johnson & Johnson in 2001, she has held positions of local, regional, and global responsibility and covered different J&J sectors, business units, functions and regions (North America, Latin America and EMEA). She has led regulatory programs from concept to approval and implementation spanning the entire medical device product lifecycle.

Glenda has extensive experience in leading large organizations through major regulation changes, with a focus on building organizational capabilities and ensuring continued and timely patient access to life-saving medical technology. Since 2016, Glenda has played a strategic leadership role in the preparation for and implementation of the EU MDR (Medical Device Regulation), and more recently, UKCA and Swiss MedDO, ENVI requirements, for all J&J MedTech companies.

Currently, Glenda leads Regulatory Affairs in EU markets ensuring successful execution of the global innovation agenda as well as life cycle maintenance of an extensive medical devices portfolio.

Glenda has a master’s degree in chemical engineering from Stevens Institute of Technology and a bachelor’s degree in chemical engineering from the University of Sao Paulo.

Martin Penver is the Team Leader for product assessment at TÜV SÜD Denmark ApS, MDR notified body CE2443.
Using his experience gained from working within Notified Bodies for the past 14 years, he has helped implement streamlined procedures to improve conformity assessment activities in terms of transparency, timelines, predictability, and consistency. He has represented several Notified bodies at European discussions on the MDR requirements and helped draft technical information and regulatory guidance between a notified body and a manufacturer.
At TÜV SÜD Danmark ApS, he has created structured dialogues with manufacturers as part of the normal pre-application activities, and written guidance on how manufacturers can complete self-assessments for a smoother and faster process to avoid incomplete applications to the notified body.

Biography available soon

Larissa is the Regulatory Affairs Manager at Becton Dickinson and Company (BD), one of the largest global medical technology companies. Larissa’s journey began by working with quality management systems. About five years ago, she transitioned to the medtech industry, where she found her passion. In 2020, she joined BD, where she now leads the EU Authorised Representative and Swiss Authorised Representative team. Larissa has been involved in developing and implementing the activities for these entities, new processes and team, ensuring compliance with the Medical Device Regulation (MDR), in vitro Diagnostic Regulation (IVDR), and the new Swiss ordinances, MedDO and IvDO.

Markus holds the position of Director of Global Post-Market Surveillance, overseeing global PMS teams for the Orthopaedics, Sports Medicine and Advanced Wound Management business units at Smith+Nephew, a leading global medical technology company. In his previous role within the EU MDR Project team, Markus led the Post-Market Surveillance work stream. In this capacity, Markus ensured the accurate interpretation and implementation of EU MDR requirements throughout the organization.
With a background in law specializing in information law, Markus is deeply passionate about data. He endeavours to transition from traditional document-centric work to more data-driven methodologies. Markus is a founding member of MDKU e.V. and currently serves as the co-chair of MedTech Europe’s PMS & Vigilance Working Group. Additionally, he contributes his expertise as a member of the MDCG Task Forces for Vigilance, PSUR, and PMS, showcasing his dedication to advancing post-market surveillance in the medical technology sector.

Amra is the Sr. Director of Global Government Strategy for MedTech at Veeva Systems. She has been in the Healthcare Industry for over 23 years, and most of those spent in large medical device companies in a variety of regulatory roles. In addition to Abbott and Bayer, she spent 13 years at Medtronic working on global regulatory advocacy, global strategy and global regulatory intelligence, which allowed her to represent the organization in a number of external working groups and hold various chair, co-chair and SME roles. In addition to her day job, she finds time to teach International Regulatory at a local University in MN and also serves on the board of a non-profit called WISE (Women initiatives for self empowerment) focused on ensuring young women in underserved and immigrant communities understand healthy relationships and have opportunities to finish schooling.

Mr Nebojsa Serafimovic is an assessor for clinical investigations with medical devices and performance evaluations with in vitro diagnostics at the AGES/BASG. Besides approving studies he is involved in the development of national processes to tackle MDR and IVDR requirements. Prior to his work at the Competent Authority, Nebo worked for Philips Austria in the field of medical device engineering and the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM in Vienna. Nebo is member of the Clinical Investigation and Evaluation Working Group, contributes in a number of taskforces and is lead of the EUDAMED oversight board CIPS module.

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience”.