Speakers
Bassil Akra
CEO and Owner of Akra Team, Germany
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to…
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Antoine Beis
Projects Director & Certification Officer, EMD Technologies, Canada
Mr. Beis, 58 years old, has served as R&D director, then Project Director and Regulatory officer at EMD since 2004.…
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Marta Carnielli
Head of Certification IVD, TÜV SÜD Product Services, Germany
Marta Carnielli works for TUV SUD as Head of Certification IVD; in this role, she is responsible for the certification…
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Koen Cobbaert
Senior Manager – Quality, Standards and Regulations at Philips, Belgium
Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents…
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Daniel Delfosse
Vice Director, Head of Regulation & Innovation, Member of the Executive Board, Swiss-Medtech, Switzerland
Daniel Delfosse, Dr.sc.techn., is Vice-Director and Head of Regulation & Innovation at the industry association Swiss Medtech. His mantra is…
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Maria E. Donawa, M.D.
President, Donawa Lifescience & EAAR Board Member, Italy
Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six…
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Flora Giorgio
Head of Unit, D3 for Health and Food Safety (DG SANTE) at the European Commission, Belgium
Flora Giorgio is a trained pharmacist and joined the European Commission in 2006 to work in DG Information Society and…
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Leo Hovestadt
Director Governmental Affairs EU, ELEKTA | Nucletron, Netherlands
Leo Hovestadt is EU Director Governmental Affairs, with more than 30 years of experience in the medical device industry at…
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Alexandre Jauniaux
Head of Division Medical Devices, FAMHP, Belgium
Alexandre holds a master degree in biology with an orientation in biotechnology. He started his career in 2006 working in…
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Alex Laan
Head of IVD Notified Body, BSI Group, The Netherlands
Engineer (Dipl.-Ing) in Bioprocess technology and Biochemistry. Worked as a product specialist in immunohematological products and plasma products with Sanquin…
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Nils-Åke Lindberg
Founder of QAdvis & EAAR Board Member, Sweden
Nils-Åke has more than 35 years of experience in the medical device industry. He is based in Sweden and as…
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Milad Masjedi
Global Medical Devices Technical Manager, SGS – SGS Belgium NV
Milad has a PhD in bioengineering, and after over 4 years of research in clinical settings, he embarked on a…
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Heloise Mignot
Regulatory Affairs Specialist, European Medicines Agency, Netherlands
Heloise is a pharmacist with a master degree in the development of advanced therapies, biotech drugs and vaccines. After a…
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Ludger Möller
President, MDSS GmbH & EAAR Chair, Germany
Ludger Moeller, Dipl. Ing. RWTH Aachen ▪ Executive Partner Medical Device Safety Service GmbH (MDSS) ▪ Founder MDSS Consulting GmbH,…
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Claire M. Murphy
Consulting Partner, Tecno-med Ingenieros, SL, Spain
From Cork – Ireland Lives in the Penedès region near Barcelona, Spain Co-founder and Partner at Tecno-med Ingenieros S.L. (1995…
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Sarah Panten
Co-Founder, Managing Partner, Product & Strategic Business Development at avasis solutions GmbH., Germany
Sarah has a background in medical technology and has worked in various positions since 2007. Initially, she worked as an…
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Anna Pietersma, PhD
DEKRA Medical Reviewer, Netherlands
Anna Pietersma is a DEKRA Medical Reviewer and Trainer specialized in medical device clinical evaluation and post market clinical follow-up.…
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Patrick Pille
Director Verification & Registration MDSS, Germany
Starting in the PRRC Trainee Program, Dr. Patrick Pille joined MDSS as a Consultant in 2020. He has focussed on…
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Patrick Ponsaerts
Manager Healthcare, GS1 Belgium & Luxembourg
Patrick Ponsaerts joined GS1 2018 after a long experience in information system management in big companies such as Nestlé. He…
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Helene Quie
Founder & CEO, Qmed Consulting & EAAR Board Member, Denmark
Helene Quie has a master’s degree in science specialised within Cellbiology from the University of Odense. Helene has more than…
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Mika Reinikainen
UKRPA Chairman, Managing Director, Abnovo, UK
Mika Reinikainen is a founder and past Chairman of the European Association of Authorised Representatives (EAAR) and the current Chairman…
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Merlin Rietschel
Senior Manager Medical Devices, MedTech Europe
Merlin is the leading coordinator of all activities which support members in their implementation of the Medical Devices Regulation (MDR)…
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Jean-Francois Roche
D3 Medical Devices, DG SANTE, European Commission, Belgium
J.F. Roche is responsible for Vigilance of Medical devices at European Commission, DG SANTE and Chair of the EU Vigilance…
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Françoise Schlemmer
Director Team-NB (Medical Devices Notified Bodies Association), Belgium
Olga Tkachenko
Policy Officer at European Commission, Belgium
Olga Tkachenko graduated with an MSci and BA in Natural Sciences (Biochemistry) from the University of Cambridge in 2013 and…
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Vincent van der Meer
Senior Consultant, Medical Device Project B.V., Netherlands
Possessing an educational background in Life Sciences and a career transition from IT consulting to the medical device industry, Vincent…
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Kirsten Van Garsse
Qarad RA Director and Head of Qarad in-country Representative Services, Belgium
Kirsten Van Garsse obtained her master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has…
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Annette J. van Raamsdonk
Lead Quality & Regulatory Affairs Consultant, Emergo by UL – Netherlands
Annette van Raamsdonk, LL.M. is the Lead Quality & Regulatory Affairs Consultant at Emergo’s office in The Netherlands. She gained…
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Erik Vollebregt
Partner, Axon Lawyers, The Netherlands
Erik specialises in EU and national legal and regulatory issues relating to medical devices. He is an expert in life…
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