Symposium Speakers

  • Mika Reinikainen , UK I Congress Chair

    Mika Reinikainen , UK I Congress Chair

    Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).  He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. 
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  • Bassil Akra, Germany

    Bassil Akra, Germany

    Dr. Bassil Akra is the vice president of the global focus teams (Cardiovascular, Orthopedic, Active Implantable, Aesthetic Devices and Clinical) at TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. 
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  • Ronald Boumans, The Netherlands

    Ronald Boumans, The Netherlands

    Ronald’s work currently focusses on Clinical Evaluation Reports for high risk devices, but he also helps manufacturers with strategic decisions. He has a wide range of experience in borderline cases, where the product status is not immediately clear or where the risk class is an issue. He is also involved in market surveillance cases, where competent authorities need to be informed adequately. 
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  • Sandra Ferretti, Belgium

    Sandra Ferretti, Belgium

    With a near to 20 years of employment at Obelis s.a. as Chief Compliance Officer, Sandra Ferretti  has a unique expertise in European regulatory affairs both in cosmetics and medical devices fields. Her specialties: Regulatory affairs, cosmetics, medical devices, responsible person, authorized representation, quality assurance, policy making, European associations representation, company law, social law, business administration, public subventions. 
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  • Robert Ginsberg, Sweden

    Robert Ginsberg, Sweden

    Mr. Ginsberg specializes in software regulatory issues relating to medical devices and modern software engineering methods, for example Scrum or Lean Software development. He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. 
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  • Erik Hansson, Belgium

    Erik Hansson, Belgium

    Deputy Head of the Health Technology and Cosmetics Unit of the DG for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) of the European Commission.
    Erik joined the cosmetics and medical devices unit of the European Commission in 2012 to lead the implementation of the PIP Action plan, followed by the negotiations on the new Regulations.
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  • Amanda Maxwell, UK

    Amanda Maxwell, UK

    Amanda Maxwell is Medtech Regulatory Affairs Editor at Medtech Insight.
    She has some 30 years’ experience in reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products.
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  • Ludger Möller, Germany

    Ludger Möller, Germany

    Since 2000 President Medical Device Safety Service GmbH (MDSS)
    Founder MDSS Consulting and ITN Holding GmbH
    Co-Founder and Vice-Chairman European Association of Authorized Representatives (EAAR)
    1996-2000 Lead Auditor and Expert with leading Notified Body (TÜV Rheinland)

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  • Valerie Nys, Belgium

    Valerie Nys, Belgium

    Mrs Nys is currently Program Manager at Federal Agency for Medicines and Health Products (FAMPH). She implements the new European Regulation for Medical & In Vitro Devices (MDR/IVDR). She a member of European workgroups following the implementation of the regulation.
    Mrs Nys attained her degree Economics at Louvain School of Management. She is an Experienced Program Manager with a demonstrated history of working in government administration. She has been working in the health sector in Belgium for 20 years.
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  • Peter O'Blenis, Canada

    Peter O'Blenis, Canada

    Peter O’Blenis co-founded Evidence Partners in 2008 to develop leading edge technology that helps researchers deliver higher quality evidence, faster. The company’s core product, DistillerSR, is now the world’s most widely used literature review software. 
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  • Dario Pirovano, Belgium

    Dario Pirovano, Belgium

    Dario Pirovano has over 30 years experience in Medical Technology, as designer and regulatory affairs expert. He worked for 7 years as R&D and regulatory manager with Ohmeda in Milan signing some 20 project for anesthesia machines, lung ventilators and neonatal care devices. He worked for 4 years within the Commission of European Communities where he contributed to the drafting and negotiating 90/385 /EEC and 93/42/EEC directives.
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  • Sarah Sorrel, France

    Sarah Sorrel, France

    Sarah Sorrel has more than 30 years of experience of medical device regulation and clinical trials with an emphasis on emerging technologies. She is founder and President of MedPass International, the leading European CRO and consultancy for the development and market access of new medical technologies. 
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  • Dirk Stynen, Belgium

    Dirk Stynen, Belgium

    Dirk Stynen has a Ph. D. in Biology and a Postgraduate Degree in Enterprise Economics (K.U. Leuven). He was a postdoctoral fellow at the University of Pennsylvania. Dirk is widely experienced in scientific research, diagnostic assay development, quality system implementation, regulatory affairs and IVD performance evaluations. 
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  • Erik Vollebregt, The Netherlands

    Erik Vollebregt, The Netherlands

    Erik Vollebregt partner at Axon Lawyers
    Erik specialises in EU and national legal and regulatory issues relating to medical devices. He is an expert in life sciences regulation at EU and Dutch level. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. 
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