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.

Sabina is Regulatory Strategy Principal at Notified Body TÜV SÜD and acts as representative of TÜV SÜD and Notified Bodies at European level. She is Chair of NBCG-Med, the EU Commission’s working group of Notified Bodies, and Vice-President of Team-NB, the EU Notified Bodies’ association.
Sabina has 20 years of experience as pharmaceutical and medical device regulator, serving subsequently in the Medicines Evaluation Board, the Ministry of Health and the governmental organization for clinical investigations in the Netherlands.
She has worked in medtech industry as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations on corporate level and was involved in EU MDR/IVDR implementation.
Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS). She is a regular speaker and faculty member in educational conferences on regulatory topics.
She was co-founder and Chair of the RAPS Netherlands Chapter. She is Fellow of RAPS since 2015 and serves in RAPS Global Board of Directors since 2020.
Sabina holds a PharmD from Leiden University.

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.

Qualified to a master’s degree in biotechnology, based in Geneva-Lausanne area in Switzerland and working as a Vice President Regulatory Affairs EMEACLA (Europe, Middle East, Africa, Latin America, and Canada). In my current role I am directing and influencing regulatory strategies and guide the company through multiple regulatory changes and dynamics, including investment into capabilities. I also have a special focus on regulatory and clinical pathways for marketing authorization and patient access, that also includes the risk benefit approach in clinical evidence and Real World Evidence especially for therapies that address unmet medical needs.
Prior to joining Edwards I was a Sr. Director Regulatory Affairs EMEA at Medtronic, headed up Regulatory Affairs at Colgate-Palmolive Europe Sarl. in Basel, Switzerland. I have previously held the management positions in Research and Development, Manufacturing Process Management and Quality Assurance at Unilever company. And have also worked as an independent consultant to the cosmetic industry and for alternative toxicological
methods.

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.

More recently Theresa has worked as a consultant to the Medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.  Theresa re-joined BSI in August 2020, and is a principal technical specialist in the Medicinal and Biologics Team.

Theresa is a regular presenter on combination products in the EU and is the chair of the Team-NB Working Group for Rule 21 Devices, she regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.

João is a Doctor of Pharmacy (PharmD) and Associate Director of Regulatory Strategy at the Abbott Quality and Regulatory group.
In his role, he supports Abbott businesses with regulatory intelligence, strategic direction and technical guidance in the implementation of new regulatory regimes or in regulatory transformation programs, such as implementation of the EU MDR/IVDR, Eurasian regime, UK and Switzerland’s new regulatory frameworks.
João participates to various MedTech Europe’s Working Groups (WGs) and currently serves as the chair of the Economic Operators WG at MTE.
Prior to joining Abbott, João worked for other medical device manufacturers as well as a MedTech regulatory consultant.

Rob Nelissen is professor and chairman department Orthopaedics, Rehabilitation, Physiotherapy at Leiden University Medical Center (LUMC). Title doctorate thesis (1995): ‘Fundamental aspects of the clinical evaluation of total joint prosthesis’. After his orthopaedic training (Leiden), he finished a Total Joint Fellowship in the USA (1993). 2005 Professor Experimental Orthopaedics. 2006 Chairman and professor Orthopaedics LUMC. 2016 Medical Delta Professor at Delft University of Technology. He was (vice)president of the Netherlands Orthopaedic Association (NOV) (2014 – 2018). He is the co-founder (2007), former chairman of the Dutch Arthroplasty Register (LROI) which is the third largest implant registry worldwide (> 1 million implants, completeness 99%). The LROI is a quality and traceability Register of implant surgery and patient outcome. Currently he is chairing the registration council of LROI. He is Secretary General of EFORT, co-chairman / co-founder of N.O.R.E. (Network Orthopaedic Registries of Europe).
Since 2019 he is observer CIE workgroup of MDCG (Medical Device Coordination Group) DG SANTE European Commission. Chairman Expert Panel Orthopaedics Trauma Rehabilitation Rheumatology under the MDR (EU commission, EMA).
His research relates to “optimising clinical outcome” and “prediction modelling of outcome”. The latter relates both to fundamental research as well as healthcare evaluation research. He published about 500 peer-reviewed articles, with focus on healthcare evaluation and prognostic modelling and optimizing outcome in arthroplasty patients. He successfully supervised over 60 PhD students.

As a natural scientist in the field of chemistry and pharmacy and a doctorate in scientific medicine, Christina began her career as a chemical development engineer in the building and construction industry within the field of explosives. Subsequently she took over market surveillance and enforcement tasks in the areas of medical devices, IVDs and radiation protection as head of Medical Devices in the Office of Public Health of Liechtenstein which is the Competent Authority for medical devices and IVDs in Liechtenstein. In April 2019 she continued her career at BVMed, the German Medical Technology Association, where she took over responsibility for regulatory affairs with a focus on medical devices but also environmental and sustainability.