MedDev Day - Speakers

Francesco Dell’Antonio, biomedical engineer with >15 years experience in the medical device industry in either notified body and manufacturing companies, including IVD. Strong expertise in complex active devices, supporting all the business processes to bring and maintain them on the market in compliance with worldwide regulations. Sound experience managing EU and extra-EU counterparts, to enable the access to key foreign markets (US, Korea, Japan, Canada, Brazil etc), with impressive success track in international approvals.

Graduated in Chemistry and Pharmaceutical Technologies at the University of Genoa, she has more than twenty years of experience in the field of CROs. She has worked as Project Manager for numerous clinical projects for the most important pharmaceutical companies and for Health Institutions. After having held the role of Clinical Operation Manager at a CRO for some years, Laura is now the Scientific Director of Latis Srl and of Elle Research Srl, two CROs that deal with the design and conduct of pre and post-market clinical studies with medical devices, supporting manufacturer in the acquisition of clinical data on their products.

Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.

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.

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.

Marta Carnielli works for TUV SUD as IVD Technical Officer; in this role, she is responsible to gather and distribute regulatory information in the IVD field, represent TÜV SÜD in relevant regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group.
Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department.
In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.

Dr. Silvia Casagrande works as Clinical Evidence Manager in the Clinical Affairs department in Orthofix SRL. In her role Silvia defines and execute the clinical strategy for CE marking & FDA clearance/approval products in development, manages the preparation and update of CERs, PMCF plans and reports, and SSCPs. She is also involved in the preparation of operative techniques and Instructions For Use leaflets. Before she worked as Clinical Regulatory Lead in the Global Regulatory Compliance team in BSI where she was involved in the development of the processes for clinical evaluation and post-market requirements and in monitoring, maintaining and improving these processes. She also contributed to regulatory supervision of clinical oversight process and delivered internal training in these areas.
Silvia holds a MSc in Pharmaceutical Biotechnology from University of Padua, Italy and a PhD in Cancer Biology from ETH Zurich, Switzerland.

He was graduated in October 2008 in Pharmaceutical and Technological Chemistry. After a brief working experience as Polyvalent Technical Operator in research and development at Enervit S.p.a, He undertook important working experiences in Clinical Research. In detail, He worked as Study Coordinator at Oncology Department of San Gerardo Hospital in Monza and later, as Quality Assurance and Auditor GxP since 2011, at CROss Research S.A in Mendrisio. Since December 2017 he covered the role of Lead Quality Assurance and GxP Auditor at 3B Biotech Research Sagl in Lugano. On August 2019 he joined to PSI, international CRO Company, acting as Global Quality Assurance Auditor. Since January 2020 he covers the role of Head of Quality Management UNIT for OPIS Srl.
Over the years he have achieved skills in the Clinical Trial Management as well as in the check of compliance to GxP, Guidelines and Regulations, developing a global overview useful to understand the critical aspects related to a clinical trial and clinical investigations with medical devices. He is member of Medical Devices SIMeF Group, He is coordinator of SIMeF GIQAR GCP Group, coordinator of GDPR Privacy SIMeF Group, member of GDPR AICRO Group, member of Farmaceutica Younger Group.

Leon is responsible for Regulatory Affairs within a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.

I am Molecular Biologist by education working since 17 years at Roche Diagnostics in different local, regional and global roles with increasing responsibility across different countries. My broad range of experience covers from account management to product & service management, as well as complex international project management and leadership. In my spare time, I am fully dedicated to sports and support my daughter in her rowing competitions.

Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH.

Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.

Kelly Goodwin Burri is a Senior Medical Writer and Clinical Evaluation Specialist with more than 15 years of experience in medical writing, clinical research, and epidemiology. Her professional experience includes various medical writing roles in the pharmaceutical industry, operational management of multi-national clinical trials and cohort studies, as well as project leadership roles for international patient registries. She currently serves as the Chair of the Medical Device Special Interest Group for the European Medical Writers Association (EMWA).

Jan-Bart Hak is heading the medical device department of ProPharma Group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development. Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a start-up company in biodegradable medical devices, which is currently a successful company. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.

Sarah has a background in medical technology and worked in various positions since 2007. She first worked as international product manager for Olympus Surgical Technologies Europe, before she entered the QM and RA world as consultant for Prosystem AG (NSF) in 2010. With her gained knowledge and expertise, she joined the established startup iThera Medical where she was responsible for coordination of development and market access activities for the world’s first optoacoustic tomography CE marked medical device. In that position, she introduced digital processes and digital technical documentation from the very beginning and realized the huge potential for digital solutions in the medical device industry. Based on that experience, she joined avasis in 2019 and is now focusing on the development and implementation of medical device specific software solutions.

Dr. Krutarth Patel works at R-Biopharm AG in Germany as a Vice President for QM / RA, he has more than 10 years of experience In Vitro Diagnostics with hands on experience with ISO 13485, ISO 9001 and MDSAP, Council Directives In Vitro Diagnostics IVDD 98/79/EC and IVDR. Dr. Patels had various positions during his professional career in IVD industries e.g. marketing & Sales, Clinical Affairs, Product Management, R&D, Production and as an Auditor.

Wiebe Postma, PhD is a Sr Consultant and CRO Lead at Qserve group with close to a decade of experience in the medical device industry. A generalist with in-depth knowledge of the medical device regulations and clinical operations, his goal is to help manufacturers find practical solutions to clinical data collection and regulatory compliance. He has been involved in the setting up of pre- and post-market clinical investigations with medical devices in Europe, as well as clinical evaluation and post-market clinical follow-up planning for a broad range of devices and indications. In recent years, he had a leading role in the growth of Qserve’s CRO services.

Jasminka Roth is the founder and director of The Tao of Excellence. A company that provides services for strategic quality management and smart process design that is located in Switzerland – a global leader in medical technology and a hub for innovation in the industry. Jasminka is passionate about developing integrative and holistic approaches to business challenges in quality management and strategy and enabling sustainable solutions at every stage. Her leadership in quality management and business excellence for a number of high-profile companies, such as Johnson & Johnson, Novartis and a multitude of highly innovative small and midsized medical device companies has given her the specialist insight that enables her to implement creative, innovative and lasting solutions. Her long-standing experience and expertise spans healthcare, pharmaceuticals and the medical devices industry, and she is actively interested in affecting change and strengthening Switzerland’s industrial standpoint in these sectors. Jasminka holds a MSc and BSc in biochemistry and biotechnology from ETH Zürich and has carried out research at the Insel Spital in Bern and at the University of Sydney, Australia.

Born and schooled in Saint Petersburg (Russia). Graduated Saint Petersburg Pediatric Medical Academy. Attended Saint Petersburg Medical Academy of Postgraduate Education. Worked as a research and development scientist at Charles University in Prague. In 2007 became involved in regulatory affairs activities at an in vitro diagnostic company. Proceeded to build regulatory expertise working at a number of medical device companies in Germany and Russia. Since 2017 is a Regulatory Affairs Director and a co-founder of MDRC company. Completed the MBA program at the University of Nordland in 2015.

Dr. Itoro Udofia is MHS-UK Director at TUV SUD (UK). Itoro was formerly the Head of Notified Body at UL, and spent over nine years at BSI where he held several positions (including, Product Specialist, Global Head of Orthopaedics and Dentals Devices, and Head of Operations and Training). Itoro has over eighteen years of experience working with orthopaedics devices.
Itoro’s qualifications include: BEng (Hons.) Biomedical Engineering and PhD Biomedical Engineering and Computational Modelling. He is a past visiting Professor at Wuhan University of Science and Technology in China.

Danny Van Roijen is Digital Health Director at COCIR. Danny holds a Master in Business Engineering and has 15 years of experience as a public affairs professional. Coordinating the association’s digital health acitivities Danny focuses on European policy making, covering topics such as artificial intelligence, blockchain, cybersecurity, data protection, interoperability and mHealth.

Danny represents COCIR in the AI4People initiative and several EU-funded projects. Danny is also a member of the Stakeholder Cybersecurity Certification Group, established by the European Commission under the EU’s Cybersecurity Act. On behalf of COCIR, Danny is chairing the Healthcare working group within the International Association for Trusted Blockchain Application (INATBA).
COCIR is the leading European trade association representing the medical imaging, radiotherapy, electromedical and health IT industries.

Over 25 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Nutritional, Pharmaceuticals, Medical Devices, Consumer Healthcare and Biological products.
Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 3800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professionals Associations) since 2010 with over 4800 members. Wrote the first Asia Regulatory Book, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.
Adjunct Lectureship & Visiting Professorship with Nanyang Technological University (Singapore), Tohoku University (Japan), Beijing University (China), Chinese University of Hong Kong (Hong Kong), University of Hong Kong (Hong Kong), Taipei Technical University (Taiwan), University of Sydney (Australia), Dongguk University (Korea).

Encey has been with Qritive since its early stages and has dedicated more than 3 years studying and navigating a new Medtech start up through the uncharted territories of AI regulations amidst global shifts in regulatory trends. With an interest to create more meaningful discussion and deliberate dialogues in the safe development and application of Artificial intelligence in healthcare, Encey strives to learn and interact with others who are pursuing this interest as well.