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.

Philippe is a Senior Director, Regulatory Strategy and Advocacy at Abbott, following the various Abbott businesses, pharmaceuticals, nutrition, medical devices, and In vitro diagnostics devices.

Philippe also represents the European medical devices industry in various European Commission expert groups and is a trainer in meetings organized by regulatory authorities around the world. He has been serving as an industry advisor to the Global Harmonization Working Party Technical Committee since 2015.

He is the Chair or co-chair of the Post Market Surveillance, Notified Body and International Regulatory working groups within MedTech Europe, the European medical device manufacturers’ trade association.

Philippe received the Global Leadership Award from RAPS in 2010 and was elected RAPS Fellow in 2012. He has also received a Director’s special citation from the FDA Center for Devices and Radiological Health for his work with  the Global Harmonization Taskforce.

Gert is an expert in European regulations based on more than 25 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic, regulatory and business consultant.

He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers.

He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area.

For his contributions to the regulatory profession he has been awarded as Fellow of RAPS.

Gert is president of RAPS, and serves as board member of RAPS Europe.

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.

Thomas is an experienced manager who has worked with strategy, efficiency and management projects in health care, environmental and engineering.

As former director of medical devices in the Danish Medicines Agency, Thomas has worked with the Danish health care sector, MedTech industry and Patient organizations to secure patient safety.

Thomas holds a master’s degree in political science from the University of Copenhagen. In addition, he has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience in the public sector.

Thomas has recently moved to a position in the global pharma industry.

Dario Pirovano, after having worked in Italy in the R&D for a medical device company, joined the European Commission as technical expert for 4 years, where he contributed to the drafting and negotiating of the 90/385 /EEC and 93/42/EEC directives.

Dario has over 30 years’ experience in medical technology as designer and regulatory affairs expert. In 1995 he founded Pirovano Management SPRL, a consulting firm advising manufacturers, Notified Bodies and authorities in regulatory matters relating to medical technology.

Since 2002 he act as a consultant as Senior Regulatory Adviser for MedTech Europe

Dario can be considered the historical memory of the development of medical devices regulation in Europe. He holds a Doctorate in Engineering from the Politecnico di Milano.