Session one:
Vision.

Medical technologies are a very important and fast changing industry, with enormous impact on market and society, requiring a complex framework of relationships between private sector companies, national and international regulators, civil society stakeholders in both developed and developing world. What is the role of international standardization in this framework? What are the main emerging needs and challenges to be addressed?

Keynote addresses:

Dr. Vladimir Lepakhin Assistant Director-General - Health Technology and Pharmaceuticals, World Health Organization:
Helping to build better global health - Key issues to be addressed by international standardization (accessibility, acceptability, affordability, equity, adaptability, sustainability)

Prof. Erich R. Reinhardt, Head of Siemens Medical Solutions, Member of the Managing Board of Siemens AG:
Faster advances in medical technologies and global reach – an industry perspective of international standardization present and future challenges

Dr. Joshua Jacobs, Rush Medical college of Chicago, Chairman of Research and Scientific Affairs on the Board of the American Academy of Orthopedic Surgeons; Chair of ASTM committee F04 and US TAG delegate to ISO/TC 150 "Implants for surgery":
Role of standards in biomedical device testing: a surgeon's Perspective;

Mr. Cornelis Brekelmans, Global Harmonization Task Force (GHTF) Chairman:
How to minimize risks (for patients and health care institutions) without constraining innovation and harming free trade – the role of international standards and their application at regional and national levels

Mr. David Jefferys, Head of device sector, UK Medicines and Healthcare Products Regulatory Agency:
The role of standards in supporting the regulation of medical devices - the expectation of the regulators.

Mr. Donald Marlowe, Senior FDA official responsible for standards:
Use of voluntary standards by a regulatory agency

Mr. Shigetaka Miura, Executive Manager, Japan Federation of Medical Devices Association (JFMDA):
Regulations and standards. Collaboration between ISO, IEC and GHTF

Dr. Vera Costa e Silva, Director, Tobacco Free Initiative, WHO
Regulatory challenges regarding the ISO/FTC standards on tobacco product testing

Dr. Klaus Stinshoff, European RA/QA Director, Digene Sarl and Chair of ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems":
Role of standards in the assessment of medical devices

Mr. Robert Britain, Vice President Medical Products, National Electrical Manufacturers Association (NEMA)

Session three:
Standards development practices.

How to ensure optimal adherence to the set objectives and pursue the most efficient approach to the development of international standards, while preserving participation from all concerned parties, openness and transparency of the process.

Issues to be addressed in this session concern business planning of standards and priority setting approaches, the identification of the types of normative publications most appropriate for different needs (i.e. standards vs. guides and technical reports), the optimal application of procedures and adoption of tools (such as IT tools) to streamline the process, coordination of activities among WHO, the members of WSC and the various standards developing organizations.

Dr. Peter Mildenberger, Clinic for Radiology, Johannes Gutenberg University of Mainz and Co-Chair of Digital Imaging and Communications in Medicine (DICOM):
DICOM - Perspective

Dr. Donna Meyer, President, National Committee For Clinical Laboratory Standards (NCCLS):
Accelerating document production – A case study

Mr. William Dierick, Business Development Manager Medical Products - Europe, Terumo Europe N.V. and Dr. Yvan J. F. Hutin, MD, MSc, PhD, Project Leader, Safe Injection Global Network (SIGN), WHO:
WHO - ISO cooperation for the development of standards for safer injection technologies.

Mr. Pierre-André Probst, Chairman, ITU-T Study Group 16 - Multimedia Systems

Mr. Graham Holloway, Chair of ISO/TC 157 "Mechanical contraceptives":
Challenges in the development of international standards for condoms.

Dr. Toshie Tsuchiya, Director, Division of Medical Devices, National Institute of Health Sciences (NIHS):
Standards and guidelines for the sound development of the medical devices and tissue engineered products

Dr. Yun Sik Kwak, Chair of ISO/TC 215 "Health informatics":
Current ISO/TC 215 health informatics standardization activity

Chair: Dr. Alfred Dolan, Samuel Lunenfeld Professor, Institute Biomedical Engineering, University of Toronto

Session four:
New technologies and standards.

Are different approaches required to deal with existing, new and emerging technologies?

New technologies cross traditional boundaries: how to ensure early and extended coordination among different groups of stakeholders and standards developing groups in these cases?

When, if ever, should standards lead technology rather than reflect it? Analysis of alternatives and practical examples. Clear definition of the "horizontal" elements to be managed (such as terminology, interfaces, risks, traceability) in relationships with new technologies.

Mr. Richard Moore, Scientific Director, EUCOMED:
Medical nanotechnology - a new challenge for standardization.

Dr. Ana Padilla, Essential Health Technologies, WHO:
Standardization of “in vitro” biological diagnostic procedures: emerging technologies

Selection of themes/case studies concerning emerging technologies to be presented by representatives of organizations belonging to the advisory group.

Invited speakers:
Mr. Philip Brown, Quintiles Consulting

Dr. Anthony Ratcliffe– President and CEO, Synthasom:
The ASTM approach on standards for tissue engineered medical products

Mr. Charles Sidebottom – Director, Corporate Standards, Medtronic:
Standards and new technology or choosing what you want to be when you grow up

Mr. Melvin Reynolds, Institute of Electrical and Electronics Engineers (IEEE):
State of the art technology - protocols, networks and standards for point-of-care medical device communication

Dr. Emil Völkert, Chair of CEN/TC 140, In vitro diagnostic medical devices:
Standards and reference materials for laboratory medicine for better patient care

Chair: Mr. Stephen Russell, Director, Standards Management, CEN

Session five:
Development dimension.

How to identify appropriate frameworks to support the need for different levels of application of standards, and how to secure representation of developing countries' interests in the standards development process (that in turn may help to define different thresholds or performance levels).

Dr. S.H.Khotu, Director, National Health Information, South Africa:
Participating in standards development – perspectives from developing countries

Dr. Philippe Boucher, Web development officer, WHO:
Standards for Information Management

Mr. Petko Kantchev, Telecommunications Development Bureau, ITU:
Lessons Learned and Future of e-Health Services

Chair: Mr. Antonio Hernandez, Regional Advisor, Health Services Physical Infrastructure and Technology, Pan American Health Organization, WHO

Discussion panel: the speakers of the session, Mr. Holloway (ISO TC/157 "Mechanical contraceptives"), Mr. Liebler, Director, Technology & Regulatory Affairs, Advanced Medical Technology Association (AdvaMed)

Wrap-up session

Summary of each session presented by the rapporteurs: issues and proposed action plan

Discussion panel and follow-up

Closure of the workshop

Mr. Alan Bryden, Secretary-General, ISO

Dr. Steffen Groth
(WHO)

joined WHO as Director of the Department of Essential Health Technologies in the Health Technology and Pharmaceuticals Cluster in July 2003. Prior to his assignment in WHO, he was Director, for six years, of the Human Health Division of the International Atomic Energy Agency (IAEA). He obtained a degree in Medicine (specialist of two laboratory disciplines, nuclear medicine and clinical physiology) and a Masters Degree in Business Administration. He then worked as medical hospital director (CEO) and director and professor of a university institute within his medical speciality.

Mr. Kevin McKinley
(ISO)

took office as Deputy Secretary-General at the ISO Central Secretariat in November 2003. He is former Director, Standards, at the Standards Council of Canada. A Canadian citizen, Mr. McKinley first graduated in 1985 with a Bachelor of Science from the University of Ottawa where he studied Kinanthropology followed by a Bachelor of Applied Science in Mechanical Engineering.

Mr. Stephen Russell
(CEN)

presently Director, Standards Management in the CEN Management Centre with responsibility for CEN standards development and production. Before joining CEN in January 2004, he was Head of Technical Policy at the British Standards Institution and in this capacity served as the United Kingdom member of the CEN Technical Board and ISO Technical Management Board. In January 2003, Mr. Russell was elected Vice-Chairman of the CEN Technical Board and Chairman of its Technical Committee Management Group, positions he resigned upon joining the CEN
Management Centre. He graduated in 1987 as a Master of Arts in Politics and Applied Economics and worked in the British Houses of Parliament as a researcher.

Mr. Antonio Hernandez
(WHO)

is the PAHO/WHO Regional Advisor on Health Services Engineering and Maintenance. He coordinates PAHO's technical cooperation on equipment technology management, medical devices regulation and healthcare engineering and maintenance programs. He became Regional Advisor in the Division of Health Systems and Services Development in Washington D.C. in 1991 after joining PAHO in 1982 as Consultant, Engineering and Maintenance in Ecuador.
Mr. Hernandez previously worked for The Ministry of Health of Colombia as Director of the Division of Engineering and Maintenance. Mr. Hernandez has studies in the fields of electronics applied to medicine, clinical engineering, hospital engineering, technology management, and health technology assessment. He is the Spanish Editor of the newsletter E.C.R.I. Health Technology Monitor and member of the Editorial Boards of Biomedical journals as well as an active member of several healthcare engineering societies. He graduated in Electronic Engineering from the
Javeriana University in Bogotá, Colombia in 1972 and received a fellowship from the British Council and in 1974 a fellowship from the World Health Organization

Dr. Vladimir Lepakhin
(WHO)

is the Assistant Director-General - Health Technology and Pharmaceuticals, World Health Organization. Prior to joining the WHO, Dr. Lepakhin was Head of the Department of General and Clinical Pharmacology of the Russian University of People's Friendship, and Director of the USSR and then Russian Drug Authority. He was Deputy Minister of USSR Ministry of Health, responsible for Medical Sciences, Health Technology and Foreign Affairs. He is a member of several national and international academies and a Fellow of the Royal College of Physicians (London).

Prof. Erich R. Reinhardt
(Siemens, Germany)

is CEO and President of the Siemens Medical Solutions and member of the Managing Board of Siemens AG. His career with Siemens AG began in 1983 as the head of Applications Development in Magnetic Resonance (MR). In 1986, Prof. Reinhardt was promoted to head the MR Division, a position that he held until 1990, at which point he became the Managing Director of Siemens Ltd. Bombay. After completing his assignment in India in 1993, he returned to Erlangen and became a Member of the Executive Board of Medical Solutions on January 1, 1994. Three months later he was nominated as its CEO and President. In November 2001, he also became a member of the Managing Board of Siemens AG. Before joining Siemens, Prof. Reinhardt pursued research at the Institute for Physical Electronics, where he also earned his doctorate. He is a member of numerous university and industry panels.

Dr. Joshua Jacobs
(ASTM)

is currently the Crown Family Professor and Associate Chairman for Academic Programs in the Department of Orthopaedic Surgery at Rush Medical College in Chicago. He serves as the Director of the Section of Biomaterials at Rush and as an Adjunct Professor in the Department of Civil and Environmental Engineering at the McCormick Technological Institute of Northwestern University. His major research focus is on the biocompatibility of permanent orthopaedic implants, particularly joint replacement devices. He is a member of the American Institute for Medical and
Biological Engineering (AIMBE) and is Chairman of American Society for Testing and Materials Committee F04 on Medical and Surgical Materials and Devices. Joshua J. Jacobs, M.D. obtained a Bachelor of Science degree in Materials Science and Engineering from Northwestern University in 1977 and graduated from the University of Illinois Medical School in 1981.

Mr. Cornelis Brekelmans
(GHTF)

is the new Chairman of the Global Harmonization Task Force and Head of the Unit responsible for sectors of Pressure Equipment, Medical Devices and Metrology at the European Commission. In these sectors, he deals with internal market regulation, trade issues and competitiveness of industry. Before joining the European Commission in 1979 where he has since occupied several positions, he worked as a legal adviser on European affairs in a Brussels based international law firm, whose clients were major Japanese and US companies. Main fields of activity were
environmental policy, free movement of goods, technical harmonization and trade policy.

Dr. David Jefferys
(UK Medicines and Healthcare Regulatory Agency)

is Head of the Devices Sector within the Medicines and Healthcare products Regulatory Agency. He is a member of the Medical Device Expert Group of the European Union and of the EU Delegation to the Global Harmonisation Task Force (GHTF) Steering Committee. Previously Dr. Jefferys was the Chief Executive and Director of the Medical Devices Agency between February 2000 and April 2003. He trained as a physician and joined the UK Department of Health after a career in clinical and academic medicine in 1984. In 1989 he was involved in the establishment of the Medicines Control Agency in the Department of Health rising to become the
Director of the Licensing Division and an Executive Board member of the MCA. Between 1995 and 2000 he was the UK delegate to the CPMP (The Committee on Proprietary and Medicinal Products) in the European Union and also chaired the Mutual recognition Facilitation Group of the EU. Part of his previous responsibility included the British Pharmacopoeia. He has lectured extensively on medicines and devices regulation also on risk analysis and risk management. He is also a Professor of Medicine at the University of Newcastle.

Mr. Donald E. Marlowe
(US Food and Drug Administration)

is the Agency Standards Coordinator, Office of Science Health Coordination, Office of the Commissioner, U.S. Food and Drug Administration (FDA). He is responsible for the across-agency coordination of technical standards for FDA. He previously served FDA as the Director, Office of Science and Technology, Center for Devices and Radiological Health (CDRH) (1995- 2002), where he directed the laboratory programs in areas of electronics, computer science, materials science, mechanical engineering, toxicology, bioeffects, and physics. He holds several technical committee assignments and professional society memberships, including the Association for the Advancement of Medical Instrumentation (AAMI), the ASTM International (ASTMI), the American Society of Mechanical Engineers (ASME), and International Standards Organization
(ISO). He is a Past Chairman of the Board of the ASTM International and a Fellow of the American Institute of Medical and Biological Engineering (AIMBE). Mr. Marlowe holds an A.B. in Physics, a B.M.E. and a M.S.E. in Solid Mechanics.

Mr. Shigetaka Miura
(JFMDA)

is Adviser, International Standard/Regulatory at GE Yokogawa Medical Systems. He has worked as a senior manager of Manufacturing, Quality Assurance, Ultrasound Engineering, MR Engineering and Advanced Technology Center for GE Yokogawa Medical Systems. He represents the Japanese Federation of Medical Devices Associations (JFMDA) for international activities and has been a secretariat general of GHTF from July 2002 to December 2003. He is currently a Japan delegate for ISO/TC 176, ISO/TC 210 and a member of GHTF SG 3. Mr. Miura has a BS degree in mechanical engineering from Waseda University.

Dr. Vera Costa e Silva
(WHO)

has been involved at both national and international levels, in the negotiation process of the Framework Convention on Tobacco Control (FCTC), which is the first legally binding international agreement ever negotiated by the Member States of the World Health Organization; a new legal instrument that could address issues as diverse as tobacco advertising and promotion, agricultural diversification, smuggling, taxes and subsidies. Dr. Costa e Silva obtained her Ph.D. from the Oswaldo Cruz Foundation (FioCruz)/National School of Public Health (ENSP), area of Epidemiology and postgraduated as Master for Business Administration in the Health Sector at the Administration School of the Federal University of Rio de Janeiro (COPPEAD). In the 13 years of activity in her home country, Brazil, devoted to tobacco control activities from a Latin American perspective, she coordinated several meetings, conferences, training programmes within the 27 states of the country, teaching and publishing several articles in national and international scientific journals, books and newspapers, and receiving several awards.

Dr. Klaus Stinshoff
(ISO/TC 212)

serves as the current RA/QA Director with the European subsidiary of Digene Corporation. He is Chairman of ISO/TC 212 Clinical chemistry, and regulations for medical devices and is a member of the WHO Expert Panel on Health Laboratory Services and of Study Group 1 of the Global Harmonisation Task Force. He is also the convenor of CEN/TC140/WG 8 Self Testing Devices. During his business career he held senior management positions at Boehringer Mannheim, DuPont Medical and Dade Behring. As an expert on medical devices he was involved, at Swissmedic, the Swiss competent authority for therapeutic goods, in the transposition of the EU Directives on medical devices into Swiss law. Dr. Stinshoff holds a PhD in Chemistry from the University of Munich, Germany and is (co-)author of 52 publications and reviews on enzymology, clinical chemistry, and regulations for medical devices.

Mr. Robert Britain
(NEMA, USA)

is Vice President, Medical Products, National Electrical Manufacturers Association (NEMA). Mr. Britain leads NEMA’s Diagnostic Imaging and Therapy Systems Division which represents firms that manufacture medical devices in the areas of magnetic resonance, nuclear, ultrasound imaging, X-ray imaging, radiation therapy and picture archiving and communication. Before joining NEMA in 1985, Mr. Britain held a number of positions in the Food and Drug Administration. He directed the Office of Device Evaluation in the Center of Devices and Radiological Health and served as Deputy Director of the Bureau of Medical Devices. Before that, he directed first the Division of Electronic Products, and then the Division of Compliance in the Bureau of Radiological
Health. He is a member of the Global Harmonization Task Force Steering Committee and of the U.S. Department of Commerce ISAC V Committee. Mr. Britain holds Engineering degrees from the University of California and Purdue University.

Dr. Peter Mildenberger
(DICOM, Germany)

is involved in research activities in cardio-vascular diseases, liver diseases, oncology and computer application in Radiology (image processing, CAD; PACS) at the University Hospital, Mainz, Germany. He is a representative of DRG (German Roentgen Society) in the DICOM Standards Committee, Chairman of the WG Information Technology in the DRG and Consultant for Deutsche Forschungsgemeinschaft (DFG, German Scientific Foundation). He is also a member
of several German radiological societies and of the German society for medical statistics and documentation (GMDS).

Dr. Donna Meyer
(NCCLS, USA)

is speaking as President of NCCLS, a leadership position she was elected to hold from 2002 until 2004. NCCLS is a widely recognized developer of global standards in the clinical laboratory field. It is a not-for-profit, educational organization whose mission is to enhance the value of medical testing and healthcare services through the development and dissemination of consensus standards, guidelines, and best practices. She is currently providing leadership for all community health services for the CHRISTUS Health system and is a Diplomate of the American College of healthcare Executives. Dr. Meyer has had many years of experience as a health care provider beginning her career as a microbiologist then as a laboratory director. More recently, she has served as a healthcare administrator, managing laboratories, radiology, pharmacy and other ancillary services. In addition to serving as a volunteer on the NCCLS Board of Directors and Executive Committee, she serves on the Boards of Directors for a number of other healthcare and social service organizations in the USA and Mexico. Dr. Meyer earned her BS and MS degrees from the University of Minnesota and her Ph.D. degree from the University of Texas School of Public Health.

Mr. William Dierick
(Terumo, Europe, NV)

is Business Development Manager - Medical Products, Terumo Europe NV, a global research & development company, offering a wide range of quality products in angiography, cardiology and cardiovascular systems, transfusion, patient monitoring and medical and clinical systems. Over the past 27 years, Mr. Dierick has held increasingly responsible positions in Terumo, covering quality assurance, product development, manufacturing, technical engineering and project management.
Mr. Dierick serves as active member of Eucomed, and is the ad-hoc workgroup convener of ISO/TC84/SC1 and board director of the International Association of Safe Injection Technologies.

Dr. Yvan J. F. Hutin
World Health organization

is Project Leader, Safe Injection Global Network (SIGN) an international coalition of stakeholders working together towards the safe and appropriate use of injections. He is a medical epidemiologist who works on the prevention of infections with bloodborne pathogens, including HIV/AIDS and viral hepatitis. Prior to joining the WHO, Dr Hutin was employed at the CDC based Epidemic Intelligence Service (EIS) at the Hepatitis Branch in Atlanta, GA, USA. He has extensive public health experience in Africa, Eastern Europe and Asia. Dr. Hutin, MD, MSc, PhD, graduated from the Paris medical school and specialized in hepatology.

Mr. Pierre-André Probst
(ITU-T SG 16)

serves as Chairman of ITU-T Study Group 16 responsible for the standardization of multimedia systems, services and terminals and is an independent consultant in the area of ICT. As an engineer Mr. Probst held several managerial positions within Telecom PTT and later with Swisscom, notably as Executive Vice President and member of the Management Board with responsibility for the Network Services Division (strategy, planning and implementation of Swisscom network platforms), and again as Executive Vice President, member of the Management Board with responsibility for the "Corporate Operations" business unit (activities benefiting the entire group, such as communications, legal service, international affairs, regulatory
affairs, quality and environment management as well as major projects, e.g. “Year 2000” (Swisscom). From 1999 to 2000, Mr. Probst was Head of External Relations, having relations with international organizations (UIT, ETNO, ETSI, etc.) and with the Swiss political and economical bodies. He started his professional career as a Research assistant at the High Frequency Institute of the Swiss Federal Institute of Technology in Zurich (research work and tutor) in the early seventies.

Mr. Graham Holloway
(ISO/TC 157)

is the Chair of ISO/TC 157 Mechanical contraceptives and currently holds the post of Head of Strategy and Systems Development at the South African Bureau of Standards (SABS). Mr. Holloway is also very involved in regional standardization in Southern Africa, and presents a number of training courses on various aspects of standardization as well as chairing a number of national standards committees. He is a sound believer in the need to increase the level of participation of developing countries in international standardization. A chemist with experience in various industries, Mr. Holloway was formerly Manager of Chemical and Biological Standards at the SABS.

Dr. Toshie Tsuchiya
(NIHS)

is Director, Division of Medical Devices at the Japanese National Institute of Health Sciences where she is responsible for in vitro toxicity tests, safety evaluation of biomaterials and for safety evaluation of medical devices and tissue engineered medical Products. Prior to her present position, Dr. Tsuchiya was Chief, Division of Medical Devices and previously a senior researcher in the Division of Medical Chemistry. She is the Japanese leader for ISO/TC 194 Biological evaluation of medical devices and is an expert in ISO/TC 150/ WG 11 Tissue engineered Implant.
Dr. Tsuchiya is a graduate of Kyushu University.

Dr. Yun Sik Kwak
(ISO /TC 215)

is Chair of ISO/TC 215 Health Informatics and is currently playing a leadership role in medical informatics in Asia as the President of Korean Society of Medical Informatics, Chair of Health Level 7-Korea, President of Asia Pacific Association of Medical Informatics (APAMI), Asia Pacific representative Board Member of International Medical Informatics Association, and Chair of a new APAMI WG of Health Informatics Standardization. He also serves as the Deputy Regional Commissioner for Asian Civilian Laboratories, Commission of Laboratory Accreditation of College of American Pathologists. He teaches medical informatics at Kyungpook National University
School of Medicine and Graduate School. He received an M.D. degree from Kyungpook National University, Daegu, Korea and a Ph.D. from Albany Medical College, Albany, NY, USA.

Dr. Alfred Dolan
(University of Toronto)

runs his own consulting business, Canadian Medical Engineering Consultants, and is the Samuel Luenenfeld Professor in Clinical Engineering and Graduate Coordinator for the Clinical Engineering Program at the Institute of Biomedical Engineering, University of Toronto. He has also been Technology Advisor to the Canadian Hospital Association and Canadian Dental Association. Dr. Dolan has over thirty five years experience in the health care field across North America, progressing from research in the thoracic and cardiovascular field to clinical management and, finally, to health care program management and teaching. He is Chairman-elect of the Board of Directors for the Association for Advancement of Medical Instrumentation and sits on various boards including the Standards Policy Board of the Canadian Standards Association.

Mr. Richard Moore
(Eucomed)

is the Scientific Director at the European Medical Technology Association and as such oversees all standards work within Eucomed. He is responsible for Eucomed’s environmental programme, and has a particular interest in new technologies such as advanced materials science, human tissue engineering and nanotechnology as applied to medicine, for which Eucomed has recently established a new working group, and also in risk management. Prior to joining Eucomed in 1997, Mr. Moore was Project manager for healthcare, later taking on responsibility for biotechnology and environmental affairs at the European Committee for Standardization. From 1983 to 1991 he was Project Manager at the British Standards Institution where he worked in several technical sectors within BSI’s chemical and health department and was responsible for a number of ISO subcommittees and working groups.

Dr. Ana Padilla
(WHO)

is the WHO Officer responsible for the area of Blood Products and related Biologicals. During the last 5 years, she has been the project leader for the development of several main International Standards for the standardization of in vitro biological diagnostic procedures applied to the detection of blood-borne infectious agents. These standards form the basis for the current worldwide regulations in blood products safety. Before joining WHO she was in charge of the Blood Products and Biotechnology Department at the National Control Laboratory in Spain and was a member of the main related scientific and regulatory groups within the European Union, such as the European Pharmacopoeia and the Biotech Working Group. She obtained degrees in Biochemistry and Pharmacy at the University Complutense of Madrid, Spain and graduated in Public Health from the same University. Her training in the production and control of biological products at the Pasteur Institute Production in France together with her PhD in Hematology at the National Institute for Biological Standards provided her with a solid background in the biological field.

Mr. Philip Brown
(Quintiles Consulting, UK)

is working for Quintiles Consulting in their Business Unit covering human and animal tissue products. Prior to Quintiles, he spent 6 years working as Regulatory Affairs Manager for Genzyme Biosurgery, being primarily responsible for their autologous and xenogenic tissue programmes including orthopaedic and cardiovascular applications. Before Genzyme Biosurgery, he worked for 19 years with Smith & Nephew, holding a number of positions including the regulatory affairs responsibility for the allogenic tissue products. Mr. Brown holds a Degree in Chemistry and is
currently a Fellow of the British Institute for Regulatory Affairs. He has worked within the medical device Regulatory Affairs industry for the last 15 years, the last 10 of which has been directly involved with medical products comprising or manufactured from human and animal tissue.

Dr. Anthony Ratcliffe
(Synthasome, USA)

is President and CEO of Synthasome, Inc., a new biotechnology company in San Diego specializing in tissue engineering and reparative medicine. Formerly, he was Vice President for Research at Advanced Tissue Sciences in La Jolla prior to which he worked as a research scientist at The Kennedy Institute for Rheumatology, London and later became Associate Professor of Orthopaedic Biochemistry at Columbia University, New York. Dr. Ratcliffe has focused his research on connective tissue biochemistry, musculoskeletal research, and tissue engineering. He has served as a member of the Board of Directors of the Orthopaedic Research Society, Study Sections for NIH, Chairman of the Grant Review Committee for the Orthopaedic Research and Education Foundation, Co-Chairman of the Tissue Engineering Committee for ASTM, and has published more than 100 papers. Dr. Ratcliffe obtained his B.Sc. in biochemistry in 1977, and Ph.D. in immunology in 1980, from the University of Birmingham, UK.

Mr. Charles Sidebottom
(Medtronic, USA)

is the Director, Corporate Standards for Medtronic, Inc., Minneapolis, Minnesota where he is responsible for the corporate standards program. He represents Medtronic at national and international standards organizations on standards matters affecting the medical device industry. Heavily involved in international standards work since 1987, Mr. Sidebottom serves as Secretary to the International Electrotechnical Commission (IEC) subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice and Membership Secretary of ASTM Technical Committee (TC) F04, Medical and surgical materials and devices. He participates as a U.S. delegate to a number of ISO and IEC technical committees, subcommittees, and working groups including ISO/TC 150, ISO/TC 210 and IEC/TC 62. He has been particularly active in the continuing evolution of symbols for labelling of medical devices and is the author of International Labelling requirements for medical devices, medical equipment, and diagnostic products. He received a B.Sc. degree in electrical engineering in 1968 from Iowa State University, and an M.Sc. in electrical engineering from the University of Missouri in 1979. He is a registered professional engineer.

Mr. Melvin Reynolds
(IEEE)

established AMS Consulting in 1996, a consultancy partnership specialising in the use of information in, and application of technology to, healthcare. This consultancy currently has commercial contracts in healthcare provider & business-to-business sectors for deployment, marketing, and development of medical device and information systems. He was formerly employed by a supplier of medical and laboratory instrumentation, initially in sales but later in product management, sales management, marketing and, finally, as the international business manager for clinical information systems with full business responsibility for all research, development, marketing and sales aspects of clinical information systems business worldwide. Mr. Reynolds is the convenor of both CEN and ISO WGs on health informatics and is Vice-Chair of IEEE 1073 Medical Device Communication. He is a member of numerous professional societies and of the European Society for Computing and Technology in Anaesthesia and Intensive Care (ESCTAIC). He is the author and co-author of numerous scientific and technical papers. Mr. Reynolds trained in physiology and pharmacology with a strong biochemical input.

Dr. Emil Völkert
(CEN/TC 140)

is Senior Vice-president of Integrated Healthcare Diagnostics. He is Board Member of the German Diagnostic Manufacturers Association (VDGH) and chairs the Working Party on standardization at the European Diagnostic Manufacturers Association (EDMA). His activities in standardization involve the chair of CEN/TC 140 on in vitro diagnostic medical devices, the participation at ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems. He also participates in several working groups at DIN. Since 1999 he is on the Board of NCCLS and serves presently as the organization’s secretary. After his studies he joined Boehringer Mannheim in Mannheim, Germany, now Roche Diagnostics, where he took up a number of different functions in his career, evaluation, applications and automation, product management and marketing and sales. Dr. Völkert studied Chemistry at the University of Technology in Vienna and received his Ph.D. from the University of Saskatchewan, Canada.

Mr. Petko Kantchev
(ITU)

is an independent consultant involved in Telemedicine/e-health. From 1999 to 2003, he assumed the responsibilities of “ITU Telemedicine Coordinator” during which he was involved, from the start up of the elaboration of telemedicine project concepts up to their deployment & commissioning, in Senegal, Guinea, Uganda, Mozambique, Rwanda, Zimbabwe, Ethiopia, Sudan, Kenya, Mauritania, Bulgaria, Bhutan, Russia, Algeria, Oman, Lebanon, Nicaragua, and Uzbekistan. He served also as ITU Focal Point to ITU-D Study Question 14/1-2 Application of telecommunication in health care. Furthermore he was actively cooperating with European Space Agency and WHO as ITU Project Manager to TM Alliance Project Telemedicine 2010: Visions for a personal medical network, funded by the Information Society Technologies Directorate of the European Commission. He joined the former Technical Cooperation Department, nowadays the Telecommunication Development Bureau (BDT), of the International Telecommunication Union, Switzerland, in 1986 as Senior Engineer, Sound and Television Broadcasting as well as a Coordinator of the Group of Engineers later transformed into the Technologies and Networks Development (TND) Group of the Telecommunication Development Bureau ( BDT). Mr. Kantchev participates in the work of several ITU-D, ITU-R and ITU-T study groups and working parties. He graduated from the Technical University of Sofia, Bulgaria, with an MSc Engineering degree in high frequency radiocommunications.

Mr. Michael J. Miller
(AAMI)

has been the CEO of the Association for the Advancement of Medical instrumentation (AAMI) since 1969. AAMI is a non-profit membership organization whose mission is to enhance the ability of the professions, healthcare institutions, and manufacturing and other industries to develop and use safe and effective medical instrumentation and related technologies. AAMI's diverse membership, consisting of over 5000 healthcare professionals, accomplishes its objectives through national and international standards, publications, education, communications, networking, certification of technical personnel, and other programs. Mr. Miller has been directly
involved with the development of medical device legislation and regulation, which provides for governmental use of mandatory and voluntary standards. He is a past member of the Board of Directors of the American National Standards Institute and has served on the ANSI Executive Committee and chaired numerous ANSI committees. Mr. Miller holds a law degree from George Washington University Law School.

Mr. Bernie Liebler
(AAMI)

is Director, Technology & Regulatory Affairs at the Advanced Medical Technology Association (AAMI). He has primary responsibility for the technical aspects of standards, testing, and certification issues relating to medical devices. He also addresses quality assurance, biomaterials, software, and other regulatory issues. Mr. Liebler is the Technical Advisor for the U.S. Advisory Groups for IEC TC 62 and SC 62A, and was a member of the ISO/IEC Joint Technical Advisory Group for Health Care Technology. He also serves on the Technical Management Committee of the U.S. National Committee of the IEC. He holds a B.S. in Physics from the City College of New York and an M.A. in Nuclear Physics from the State University of New York at Stony Brook.