Editorial Advisory Board of the Journal of Medical Device Regulation
CEO & Technical Director, Quality First International, London, UK
A microbiologist and plastics technologist with extensive experience in design and development of medical devices, regulatory assurance and Quality Management Systems implementation and compliance, Haroon was formerly Senior Professional Technical and Scientific Officer at the Medical Devices Agency, UK Department of Health. At the Agency he specialised in cardiovascular and other implantable devices, with previous roles in agricultural nematology, diagnostic microbiology and industrial development of in vitro diagnostic devices. Haroon is a recognised expert in safety and reliability engineering, as well as hazard evaluation, and has extensive experience in medical devices containing animal-derived tissue and derivatives, and drug/device combinations, notably wound care and cardiovascular devices. He also has many years of hands-on experience in preparing regulatory submissions, ranging from Product Design Dossiers, technical documentation, 510(k) notifications, IDE submissions and clinical evaluation protocols. Haroon is also a specialist EC-design examiner, a technical assessor for a number of Notified Bodies, and a CMDCAS auditor. In 2013, Haroon was appointed a Senior Member of the Royal Society of Medicine and a Member of the Society of Corporate Compliance and Ethics.
Dr Jorge E Garcia
Principal Science and Engineering Advisor, Office of Product Review, Therapeutic Goods Administration, Australia
Jorge joined the Therapeutic Goods Administration (TGA) as an incident report investigator in 1995. Since then he has contributed to a number of projects (notably on the re-use of single-use devices, safety of orthopaedic implants, and safety of devices for injection), evaluations, policies, standards development and other TGA activities. He is a member of the Association of Professional Engineers, Scientists and Managers of Australia (APESMA), and Executive Committee Member of the Australasian Society for Biomaterials and Tissue Engineering, of which he was Treasurer for 10 years. Jorge was TGA's representative at the Global Harmonisation Task Force's Study Group for the Harmonisation of Vigilance and Surveillance Systems, GHTF SG2, from 1998 until 2008. Jorge was Chairman of GHTF SG2 from 2005 until 2008 and was a Senior Advisor to Working Group 2 of the Asian Harmonisation Working Party Technical Committee (AHWP TC WG02). Currently, Dr Garcia provides advice on the management of post-market issues arising from the use of medical devices and medicines to the Therapeutic Goods Administration (TGA). He is a regulatory and scientific expert on post-market issues.
Deputy Director General, BVMed, Berlin, Germany
Rainer is an attorney at law specialising in European and German medical device legislation and regulatory affairs. He has worked for the German Chambers of Industry and Commerce in Bangkok, Tokyo, Kassel and Brussels, and in 1990 he became Director of the Legal Department of BVMed, the German Medical Technology Association. In 1991, Rainer was promoted to the position of Deputy Director General of BVMed. Since 1995, Rainer has been editing a legal commentary on German and European medical device legislation entitled WiKo – Medizinprodukterecht (WiKo – Medical Device Legislation) accompanied by an online databank (called “WiKo – Blog”) featuring more than 425 judgements on medical devices. The blog is accompanied by a free newsletter every two months featuring the latest judgements on medical devices. Rainer has also been involved in the development of a set of 11 guidelines on different aspects of medical device legislation (e.g. classification, conformity assessment procedures, clinical evaluation, market surveillance, risk management, off label use) called the BVMed-Informationsserie Medizinprodukterecht. He also co-edited a two-fold set of guidelines dealing with the professional training of medical device consultants, a German and Austrian legal particularity to support the functioning of the vigilance system. Rainer is also a co-author of the 2nd edition of the Handbuch des Medizinprodukterechts (Handbook on Medical Device Legislation, 2016) and his section of the book deals with the meaning of the CE mark for medical devices. Rainer is a member of the MedTech Europe (formerly Eucomed) Regulatory Affairs Committee and the Legal Affairs Committee, is an Editorial Board member of the legal journal MedizinProdukteRecht (MPR), and is on the Board of the DIN Commission Healthcare (Kommission "Gesundheitswesen") and the DIN Standards Committee Medicine (Normenausschuss "Medizin"). He received the German Medical Law Award 2006 sponsored by the editor of the journal MPR (PMI-Verlag in Frankfurt).
Dr David Jefferys
Senior Vice President Global Regulatory Affairs, Eisai Europe Ltd, London, UK
After a career in clinical and academic medicine, David joined the UK Department of Health in 1984 to head up the Review of Medicines. With the creation of the Medicines Control Agency in 1989, he became Director of Licensing and was a member of the European CPMP until 2000. He also chaired the Mutual Recognition Facilitation Group of the EU. He was appointed Chief Executive and Director of the Medical Devices Agency in January 2000 and on creation of the MHRA was head of the Devices Sector and joint CEO. He was a member of the GHTF Steering Committee and the EU Medical Device Expert Group. He served on the Healthcare Industry Task Force. He has also worked with the EMEA on projects concerning risk/benefit evaluation and was an advisor to the Department of Health on advanced technologies. On retirement from the DoH he now works as Senior Vice President Global Regulatory Affairs at Eisai Europe Ltd. He also advises on device issues and diagnostics. He is a visiting Professor of Medicine and external examiner in Translational Medicine to Cranfield University. His major interests are in combination products, new paradigms of product development, risk/benefit evaluation and risk communication. He has published widely on these areas and on the regulation of medicines and medical devices.
Senior Manager, Regulatory Affairs, Codman & Shurtleff, Inc, USA (retired)
With over 20 years' experience in the Clinical Research, Regulatory Affairs and Quality Assurance fields, Elena Jugo held the position of Senior Manager of Regulatory Affairs in Codman & Shurtleff, Inc, managing the Neurosurgery and Neuromodulation Regulatory Affairs groups. Prior to this, Elena worked for 18 years at Cordis Corporation, initially in the position of a Quality Assurance Auditor, and later transferring to the Regulatory Affairs department where she managed several programmes in the endovascular division, ranging from catheter sheath introducers to endovascular stent grafts for the treatment of abdominal aortic aneurysms, and combination stent/drug devices. During her career in regulatory affairs her responsibilities have included product registrations in the USA and the European Union, as well as supporting affiliate countries all over the world to gain approval of Class II and Class III devices. Before joining Cordis, Elena was employed by Telectronics Pacing Systems when they bought the pacing division from Cordis Corporation in 1987. At Telectronics, Elena managed the clinical studies of various pacing leads, pacemakers, automatic implantable cardiac defibrillators and other cardiac assist devices.
James Kuhn Jr
Regulatory Affairs Manager, ANIMAS (Johnson & Johnson Company), Chesterbrook, PA, USA
James Kuhn Jr joined ANIMAS in February 2016. He was previously employed by Siemens Medical Solutions for the last 10 years as Senior Regulatory Affairs Submissions Manager. Prior to this he had been employed at EP MedSystems as Director of Regulatory Affairs and Quality Assurance for eight years, and held various other positions such as Quality Assurance Manager, Technical Writer, QA Engineer, and Documentation Manager. His responsibilities included regulatory compliance, worldwide product registrations, domestic and international product approvals for Class II and III medical devices, and maintenance of ISO 13485/CMDR/cGMP quality systems. His major accomplishments have been the development and effective implementation of a cGMP/ISO 13485/MDD compliant QA system; Class III medical device approvals and supplements for PMAs, 510(k) submissions and attaining CE Mark. He also directed one of the first FDA Modular PMA Approvals #990069 – The ALERT System, 27 November 2002; and successful completion and closure of multiple FDA cGMP and European CE audits.
Mario R Nacinovich Jr, MSc
Managing Partner, AXON, Rye Brook, NY, USA
Mario is Managing Partner for AXON, Editor-in-Chief of the Journal of Communication in Healthcare and a member of the adjunct faculty at Boston University. He also lends his time to the editorial boards for the International Journal of Medicine and Public Health, Journal of Brand Strategy, Journal of Communication in Healthcare, International Journal of Healthcare Management, Medical Writing, PM360 – The Essential Resource for Pharma Marketers and is a founding member of the American Heart Association’s Red Tie Society. Mario has presented and moderated several executive panel discussions at many national and international conferences, contributed to numerous articles, roundtables and other types of publications on health systems, healthcare communications, public relations and media relations, key opinion leader identification, management and relations, social media and mobile health. He is a two-time recipient of the (including the inaugural) PharmaVoice 100, has received several awards of excellence from The Rx Club and the American Graphic Design Awards, and several volunteer and leadership awards from industry associations, including PM360 magazine’s Best Photo Finish Award for 2011.
Datuk Dr Mukundan Sugunan Pillay
Environmental Health Adviser, World Health Organisation, Beijing, China
Since retiring from the Government of Malaysia, Datuk Dr M S Pillay has taken on the role of Environmental Health Adviser at the World Health Organisation (WHO), based in Beijing, China. Previously, Datuk Dr Pillay had served as the Deputy Director General for Research and Technical Support in the Ministry of Health, Malaysia and also as the Director of the National Institutes of Health, comprising seven National Health Research Institutes. The Ninth Malaysia Plan for Health was planned and executed under his direction. Having graduated as a civil engineer, Datuk Dr Pillay went on to pursue his Masters in Public Health and later completed his Doctorate in Preventive Medicine and Environmental Health. He is well known professionally in Malaysia and internationally, and has chaired numerous Technical Committees. Some of these include: Chairman of the ASEAN Consultative Committee for Standards and Quality – Medical Device Product Working Group; Chairman of the Asian Harmonization Working Party for Medical Devices (AHWP); Co-Convenor of the ISO TC 224 International Standards Committee on Water and Wastewater; International Advisory Member of WHO International Committee on Non-Ionizing Radiation; Chairman of The National Strategic Plan on Waste Management; and Chairman of the National Standing Committee on Traditional and Complementary Medicine. Datuk Dr Pillay continues to advise the current Chairman of the AHWP, Mr Wang Bao Ting, who is from State Food and Drug Administration in China.
Regulatory Affairs Manager - KSA, BSi Healthcare, UK
Paul has over 30 years' experience in the healthcare industry and is currently working as Regulatory Affairs Manager - KSA, BSi Healthcare. Previously he has held senior RA/QA leadership positions in Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business) now owned by GE Healthcare. He has also undertaken regulatory affairs and quality management consultancy through his own SiMedical Device Consulting company. Device experience is across a very broad range of products including anaesthesia systems, patient monitors, vaporisers, ventilators, breathing circuits, single-use sterile disposables and devices for re-use, infant warmers, incubators, sterilisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc. His current role is leading the BSi effort with the Saudi Food & Drug Authority (SFDA) and the implementation of the SFDA Medical Device Interim Regulations, along with a number of other Conformity Assessment Bodies. Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. He is Convenor of the BSI Committee that monitors all of the work undertaken by ISO TC 210, and is Convenor of the BSI Sub-committee dealing with Quality Systems. In addition to being the UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is also a member of the CEN Advisory Board on Healthcare Standards and associated Task Forces. As a member of the ISO TC 210 Committee he provides the formal liaison between ISO TC 210 and ISO TC 176 - the international committee dealing with the revisions to the ISO 9000 family of standards. He is Chairman of BSi’s committee CH/100 dealing with Healthcare & Medical Devices (European & International Standards). He is Deputy Chairman and Council Member of the British Anaesthetic & Respiratory Manufacturers Association; he is also a Member of the Association of Anaesthetists of Great Britain and Ireland Safety Committee and was in 2010 a recipient of their Langton Hewer Award given to members of industry for their contributions to the speciality of Anaesthesia. Paul has also compiled several articles for publication in various medical device industry publications and regularly presents at medical device industry conferences in both the UK and Europe.
Edward C Wilson, Jr
Partner, Hogan Lovells US LLP, Washington DC, USA
Ted Wilson's practice is primarily in the medical device area with an emphasis on enforcement matters. He focuses extensively on post-market compliance issues including the Food and Drug Administration's Quality System Regulation (QSR), adverse event reporting, and field action requirements. His experience includes assisting in the defence of criminal investigations by the US Department of Justice; conducting internal investigations of alleged violations of federal regulations and corporate codes of business conduct; creating and implementing corrective action plans; reviewing and drafting product submissions and standard operating procedures; and providing general advice on a variety of device-related regulatory issues. Ted is a certified Quality Management Systems Auditor by RABQSA International. He performs audits for companies to determine their level of compliance with FDA's requirements and assists them in attaining regulatory compliance. He has also taught numerous courses on QSR requirements and product submissions to medical device companies around the world. Ted is a frequent speaker at medical device and diagnostic seminars and conferences. He has authored portions of several texts on device regulations, including 'A Practical Guide to Food and Drug Law and Regulation', 'Fundamentals of Law and Regulations' and the 'Medical Device Industry Fact Book', as well as a number of articles that have appeared in other publications.