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Medical Devices: Regulatory and Compliance Summit

  • 20th – 21st February 2019
  • Austria flag Austria Vienna
  • Renaissance Wien Hotel Linke Wienzeile, Ullmannstraße 71, 1150

This event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU.

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About

The Summit will shed light on classification, conformity assessment and risk management in regulatory strategies to achieve compliance and ensure patients’ safety. Through case studies, interactive presentations and discussions, attendees will learn which regulatory strategy is applicable for their products, how to develop effective tactics and how best to achieve smooth market access.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists and Engineers specialising in:

  • Medical Devices
  • Controls & Robotics
  • In Vitro Diagnostics
  • Device Design
  • Medical Device Design
  • Sterilization
  • Product Quality
  • Regulatory Affairs
  • Research & Development
  • Validation
  • Combination Products
  • CMC
  • Design Controls
  • Device Development & Manufacturing
  • Medical Device Engineering
  • Quality Assurance/Control
  • Compliance
  • Risk Management
  • Supply Chain

Key Practical Learning Points

  • Overview of guidelines, regulations and registration requirements
  • Quality management systems
  • Clinical affairs: data, evidence, equivalence and performance studies
  • Achieving a smooth market access
  • MDR impact on risk management and clinical evaluations
  • Updating technical documentation and labelling
  • Requirements for classification of medical devices
  • Higher patient safety at what price?
  • Post-marketing adverse event reporting

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Matthias Bürger is the vice president of Global Regulatory Affairs for Zimmer Biomet, the European subsidiary of Zimmer Holdings. He has a master’s in biomedical engineering from Marquette University in Milwaukee, WI, as well as a Dipl.-Ing. degree in electrical engineering from Fachhochschule Dieburg in Germany. In the past, Matthias has had a variety of different management roles in QA and regulatory affairs for companies including GE, Baxter, Terumo and Guidant. He has also worked as a quality management systems and operational consul­tant for Grant-Thornton, as well as spending time as a lead auditor and test engineer for TUV Rheinland, a European notified body for the Medical Device Directive. Matthias has spoken at a variety of international conferences, including RAPS, MD&D, ASQ, IEEE and others.

Dr. Weiping Zhong, US

Global Director, Risk Management/QARA, Clinical Evaluation, Cybersecurity Safety Risk, Statistics

GE Healthcare

Dr. Weiping Zhong has been the global director of risk management for GE Healthcare since 2012, leading risk management, cybersecurity-safety risk management and clinical evalu­ation for a variety of products covering imaging, patient care and digital healthcare. Prior to joining GEHC, Weiping held multiple positions in Bayer Healthcare – diabetes care from 2002-2012, including QA/RA head for APAC, statistician and quality engineer. He graduated from the University of Michigan (US) and Dalian University of Technology (China) in the fields of mechanical engineering, industrial/operations engineering and electric engineering.

Dr. Bassil Akra, DE

Vice President – Global Focus Teams Active Implantable, Cardiovascular, Orthopedic, Aesthetic Devices & Clinical

TÜV SÜD Product Service GmbH

Dr. Bassil Akra is the vice president of the global focus teams (cardiovascular, ortho­paedic, active implantable, aesthetic devices and clinical) at TÜV SÜD Product Service. Bassil has a lot of experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.

He is leading various consultation processes of medical devices incorporating an ancil­lary medicinal substance with the different competent authorities designated by the member states or the EMA. As a senior field expert, he is presenting worldwide the requirements in Europe and is involved in the development of several European guid­ance documents and standards.

Bassil is a member of the European Clinical Inves­tigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other guidance documents on innovative devices. He is a member of the German MDR Implementation Working Group (the NAKI) and also a member of new MDR European task forces such as the one on PSUR, SSCP, equivalence and sufficient clinical data.

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Philippe Auclair, who has a PhD in pharmacy, joined Abbott in 1994. He is currently respon­sible for regulatory strategy and advocacy. He represents the European industry in various European Commission expert groups and served through 2012 as secretary of the Global Harmonization Task Force Study – Group 2, dealing with adverse events reporting. He actively participates as a trainer in programs organised by regulatory authorities in various locations, such as Europe, Colombia, Brazil, China, India, Mexico and the United States, and since 2015 he has served as an advisor to the Asian Harmonization Working Party Technical Committee.

Philippe is chairman of the post-market surveillance and notified body working groups of Medtech Europe, the European medical device manufacturers’ trade association. He is a mem­ber of the European Advisory Committee and of the board nominating committee of the Regu­latory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010 and was elected “RAPS Fellow” in 2012. Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at GHTF.

Giacomo Cargnello, NE

Sr. Regulatory Affairs Manager & EU MDR Lead

Philips Medical Systems Nederland B.V.

Giacomo Cargnello is currently the program lead and principal SME of the MDR implementa­tion at Philips MRI, that develops and manufactures magnetic resonance devices. He is cur­rently leading the MDR governance team, which includes representatives and SMEs from all disciplines with the scope of planning and steering the MDR adoption for the MRI business unit. He is also part of the Corporate Pre-Market Task Force, which provides interpretation and guidance related to the MDR across all Philips business units. Giacomo holds a master’s in biomedical engineering and he has worked in several medical device industries covering different Q&R roles. Prior to Philips MRI, he was an RA manager at Philips IGT (interventional X-ray manufacturer). Before Philips, he worked at Baxter Healthcare starting as QA/RA R&D project manager and later APAC/Americas RA manager, dealing with the regulatory activities of Haemodialysis equipment in these two regions. He has also worked at St. Jude Medical (now Abbott Laboratories) in the implantable pacemaker and defibrillator division. In addition, he is a certified Philips Q&R auditor and lead auditor for the Medical Device Directive 93/42/ EEC, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282) and Japan’s Pharma­ceutical and Medical Device Act (jPMD Act).

Anna Mirabelli, DE

Scheme Manager & Technical Expert, Healthcare

BSI

Anna Mirabelli, who has a master’s in medical engineering, is currently working as scheme manager and technical expert for the European notified body BSI. After working for over 10 years in the medical device industry, covering different roles from process engineering to R&D, she started working for the notified body as a technical expert in the vascular team. She is also a lead auditor for ISO9001, ISO13485 and the medical device directive 93/42/EEC, as well as a CMDCAS auditor.

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Elizabeth Gfoeller is the corporate director of regulatory affairs for MED-EL, which is an EU manufacturing company privately owned and operated out of the same location. All functions (design, manufacture, distribution, etc.) are located in the head office in Innsbruck, Austria. MED-EL is active in over 115 markets worldwide with over 30 regional offices. As the leading global hearing implant company, MED-EL manufactures active implantable medical devices, namely cochlear implants, middle ear implants and bone conduction implantable and other non-implantable hearing systems and surgical devices that are marketed globally. Elizabeth joined MED-EL in 2006 and currently leads the corporate regulatory affairs function responsible for all markets for product licensing, registrations/re-certifications, post-market vigilance ac­tivities, regulatory strategies for new product developments and related compliance activities internally and externally to new regulations and standards. She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities. Before this role in medical devices, she worked as a regulatory professional in the telecommunications sector at Vodafone Ireland from 2000 until 2005 as a regulatory compliance manager and a data pro­tection officer located in their head offices in Dublin. Prior to this, Elizabeth spent many years active as both a lecturer and social researcher in South Africa. Her educational background is in social sciences, with her studies and thesis focussed on sociology. Her graduate and post-graduate studies were completed at the University of the Witwatersrand, South Africa.

Dr. Erik Raadsheer, NE

Sr. Director Regulatory & Government Affairs & Quality Assurance, EMEA

Align Technology

Dr. Erik Raadsheer is the senior director of regulatory and government affairs and quality assurance EMEA at Align Technology. Align is a global medical device company engaged in the design, manufacture and marketing of the Invisalign® system, the most advanced clear aligner system in the world, and iTero® intraoral scanners and services for orthodontic and restorative dentistry. Align’s products help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients. Erik holds a PhD in neurosciences and a master’s degree in medical biology. In addition, he is a SKO- and EOQ-certified quality manager. After a brief scientific career, Erik gained more than 24 years of experience in quality assurance (QA), environmental management (EM) and regulatory affairs (RA) in the Zuid-Limburg blood bank, Medtronic, Mölnlycke Health Care and Philips. In November 2017, he joined Align Technology EMEA, where he is responsible for all pre-market and post-market regulatory affairs activities in Europe, Middle East and Africa, as well as for QA in all facilities in the region. He is also responsible for building the strategy for stakeholder engagement at the European level across key markets of Align Technology in EMEA. Erik represents Align Technology in several focus groups of COCIR (European Coordination Com­mittee of the Radiological, Electromedical and Healthcare IT Industry).

Pedro Jorge Mendes, ES

Technical Steward Devices Novartis Technical Operations – SOLIDS Platform

Novartis Farmaceutica S.A.

Pedro Jorge Mendes graduated as a mechanical engineer with a first-class degree. He started working with medical devices in 2002 during his PhD on the study of dispersion of medicinal powder aerosols. After graduation he worked as a device engineer on devices design and development. During this period besides concept, design and development of novel devices, Pedro was responsible for the development of industrial applications, device evaluation and optimisation. He was also involved on device assembly and filling processes. Pedro joined Novartis in 2013 and since then he has been working across the devices portfolio, mainly focussed on inhalers, providing technical knowledge and support on any device-related activity. Among other things, Pedro is responsible for devices topics on the quality system, registration documents, commissioning activities of packaging equipment and process improvement, DHF and technical file maintenance, change control and PMS.

Fabien Roy, BE

Counsel

Hogan Lovells International LLP

As counsel of the life sciences practice, Fabien Roy focusses his practice at Hogan Lovells on advising clients on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. Fabien follows the new regulations on medical devices (MDR and IVDR) and the GDPR very closely and regularly advises clients on the requirements applicable to their digital health technologies. With a practice entirely focussing on complex regulatory issues faced by life sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions, enabling clients to focus on their business. Fabien focusses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures (e.g. authorisation from the EU member states competent authorities, opinion from ethics committee, amendment to the protocol, informed consent, serious adverse event qualification and notification, handling of personal data), conformity assessment and registration procedures (e.g. preparation and review of technical files, preparation and review of responses to the competent authorities’ and notified bodies’ requests) and post-market activities (e.g. adverse event reporting, field safety corrective actions and promotional and advertising of medical devices). Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device clients. Fabien also assists life sciences clients in the preparation, drafting and review of numerous agreements, including clinical study agreements, sponsors’ representative agreements, registry agreements, CRO agreements, European authorised representative agreements and distribution agreements.  

Bijan Elahi , NE

Global Product Risk Management Consultant, Educator

Medtronic

Bijan Elahi has worked in risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He is currently employed as a technical fellow at Medtronic, where he serves as the corporate expert on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequent speaker at professional conferences and is also a contributor to ISO 14971, the international standard on the application risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.

Dr. Clemens Guenther, DE

Director of Nonclinical Safety CC

Bayer AG

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany. From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strat­egy including human DMPK for development and life cycle management projects. After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals. Meanwhile Dr. Clemens Günther has gained about 30 years of experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the Universi­ty of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this department is identifying organic impurities in drug products as well as in use stability of drug-device combination. In 2017, the scope expanded and includes now also all microbiological testing offered at Nelson Labs Europe.

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Dr. Weiping Zhong, US

Global Director, Risk Management/QARA, Clinical Evaluation, Cybersecurity Safety Risk, Statistics

GE Healthcare

Dr. Bassil Akra, DE

Vice President – Global Focus Teams Active Implantable, Cardiovascular, Orthopedic, Aesthetic Devices & Clinical

TÜV SÜD Product Service GmbH

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Giacomo Cargnello, NE

Sr. Regulatory Affairs Manager & EU MDR Lead

Philips Medical Systems Nederland B.V.

Anna Mirabelli, DE

Scheme Manager & Technical Expert, Healthcare

BSI

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Dr. Erik Raadsheer, NE

Sr. Director Regulatory & Government Affairs & Quality Assurance, EMEA

Align Technology

Pedro Jorge Mendes, ES

Technical Steward Devices Novartis Technical Operations – SOLIDS Platform

Novartis Farmaceutica S.A.

Fabien Roy, BE

Counsel

Hogan Lovells International LLP

Bijan Elahi , NE

Global Product Risk Management Consultant, Educator

Medtronic

Dr. Clemens Guenther, DE

Director of Nonclinical Safety CC

Bayer AG

Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

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