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World Health Organization
Standard-setting Activities - Impact on Global
Health |
Dr. Vladimir K. Lepakhin,
Assistant Director-General
Health Technology and Pharmaceuticals, WHO |
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the presentation in pdf format (63kb) |
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Faster advances
in medical technologies and global reach –
an industry perspective of international standardization
–
present and future challenges |
| Erich R. Reinhardt, Head
of Siemens Medical Solutions, Member of the
Managing Board of Siemens AG: |
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the presentation (16.6mb)
(Zip file containing a Powerpoint presentation
and a video file) |
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| The Role of Standards
in Biomedical Device Testing: A Surgeon's Perspective. |
| 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" |
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the presentation in pdf format (4.45mb) |
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How to minimize
risks without constraining innovation and harming
free trade
The role of international standards And their
application at regional and national levels |
| Cornelis Brekelmans, Global
Harmonization Task Force (GHTF) Chairman |
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the presentation in pdf format (112kb) |
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Presentation by Mike Miller,
President,
Association for the Advancement of Medical Instrumentation
(AAMI) |
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the presentation in pdf format (25kb) |
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Links Between
Regulators and Standards Developers
Standards - fit for the purpose ? |
| David Jefferys, UK Medicines
and Health Care Products Regulatory Agency |
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the presentation in pdf format (156kb) |
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| Use of Voluntary
Standards by a Regulatory Agency |
Donald E. Marlowe, Agency
Standards Coordinator,
Office of the Commissioner, US Food and Drug
Administration |
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the presentation in pdf format (85kb) |
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| Regulations and
Standards. Collaboration between ISO, IEC and
GHTF |
| Shigetaka Miura, Executive
Manager, JFMDA |
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the presentation in pdf format (14kb) |
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Regulatory challenges
regarding the ISO/FTC standards on tobacco
product testing |
| Dr. Vera Costa e Silva,
Director, Tobacco Free Initiative, WHO |
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the presentation in pdf format (3.09mb)
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| Role of Standards
in the Assessment of Medical Devices |
| Klaus E. Stinshoff, European
RA/QA Director, Digene Sarl and Chair of ISO/TC
212 |
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the presentation in pdf format (258kb)
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the text of the presentation in pdf format
(32kb) |
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| DICOM - Perspective |
| Peter Mildenberger, MD,
User Co-Chair |
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the presentation in pdf format (564kb) |
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| Presentation by Mr. Robert
Britain, Vice President Medical Products, National
Electrical Manufacturers Association (NEMA)
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the presentation in pdf format (68kb) |
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| Accelerating Document
Production – A Case Study |
| Donna Meyer, Ph.D., President
of NCCLS |
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the presentation in pdf format (1.75mb) |
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| WHO - ISO cooperation
for the development of standards for safer injection
technologies. |
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 |
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the presentation in pdf format (905kb) |
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| Role of ITU-T
in e-health standardization activities |
| Pierre-André Probst,
Chairman, ITU-T Study Group 16 - Multimedia
Systems |
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the presentation in pdf format (218kb) |
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| Challenges in
the development of standards for condoms |
| Graham Holloway, Chair:
ISO/TC 157 “Mechanical contraceptives” |
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the presentation in pdf format (410kb) |
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| Standards and
guidelines for the sound development of medical
devices and tissue engineered products |
| Dr. Toshie Tsuchiya, Director,
Division of Medical Devices, National Institute
of Health Sciences (NIHS) |
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the presentation in pdf format (957kb) |
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| Current ISO/TC
215, Health Informatics Standardization Activity |
Yun Sik Kwak, MD.PhD,
Chair, ISO/TC 215
Department of Medical Informatics,
Kyungpook National University School of Medicine,
Daegu, Korea |
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the presentation in pdf format (3.8mb) |
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| Medical nanotechnogy
- a new challenge for standardization? |
| Richard Moore, Scientific
Director, Eucomed |
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the presentation in pdf format (418mb) |
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Standardization
of "in vitro" biological diagnostic
procedures:
emerging technologies |
| Dr. Ana Padilla, Essential
Health Technologies, WHO: Standardization of
“in vitro” biological diagnostic
procedures: emerging technologies |
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the presentation in pdf format (403kb) |
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Human Tissue Products:
Human Tissue Products:
Standardization Standardization – –
the way forward the way forward |
| Philip Brown, Quintiles
Consulting |
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the presentation in pdf format (332kb) |
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| The ASTM Approach
on Standards for Tissue Engineered Medical Products
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| Dr.
Anthony Ratcliffe, President and CEO, Synthasome,
Inc. |
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the presentation in pdf format (982kb) |
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| Standards and
New Technology or Choosing what you want to
be when you grow up |
| Charles Sidebottom, PE.
Director Corporate Standards, Medtronic, Inc. |
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the presentation in pdf format (2.31mb)
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the text of the presentation in pdf format
(309kb) |
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| State of the art
technology - Protocols, networks and standards
for point-of-care medical device communication |
| Melvin Reynolds, IEEE
(Institute of Electrical and Electronics Engineers) |
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the presentation in pdf format (4.51mb) |
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| Standards and
Reference Materials for Laboratory Medicine
for Better Patient Care |
| Emil Völkert, chairman
CEN TC 140, in vitro diagnostic medical devices |
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the presentation in pdf format (163kb) |
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| Open Standards
for information management |
| Philippe Boucher, WHO,
eHealth unit, EIP |
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the presentation in pdf format (38kb) |
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| Lessons Learned
and Future of e-Health Services |
| Petko Kantchev, Telecommunications
Development Bureau, ITU |
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the presentation in pdf format (1.33mb) |
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| 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). |
| Bernie Liebler, Director,
Technology & Regulatory Affairs, Advanced
Medical Technology Association (AdvaMed) |
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the presentation in pdf format (20kb) |
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