1. UNITED STATES OF AMERICA
CONSUMER PRODUCT
SAFETY COMMISSION
I NTERNATIONAL E DUCATION PANEL
TRAINING C HINA’S BUSINESS
AND MANUFACTURING LEADERS
DEAN W. WOODARD, DIRECTOR, OFFICE OF EDUCATION, GLOBAL
OUTREACH & SMALL BUSINESS OMBUDSMAN
ICPHSO 2013 ANNUAL MEETING & SYMPOSIUM
FEBRUARY 28, 2013
VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
2. Panelists and Moderator
Mr. Robert Daly, Director of the Maryland China Initiative at the University
of Maryland rdaly@umd.edu
Ms. Madelyn C. Ross, Director of China Initiatives and Global Consortium
at George Mason University mross3@gmu.edu
Ms. Wendy W. Kuran, Associate Vice President for Business Development
Duke Kunshan University wendy.kuran@duke.edu
Mr. Dean W. Woodard, Director of Office of Education, Global Outreach &
Small Business Ombudsman dwoodard@cpsc.gov
3. Facts about US-China Education
Exchanges
• 194,029 Chinese students in U.S. universities-2011 to 2012
(growing 23% per year) average (source: Institute of International Education)
• 38.4% undergraduate 45.6% graduate students 16% short
term training
• New York University and Duke University are first to have a
“brick and mortar” presence in China
• U.S.-Chinese collaboration in dual degree programs is
increasing
• 70 U.S. universities have some type of presence in China
• The failure rate of requests for collaboration by U.S. based
universities is approximately 60%. These are for dual
degree, summer, and other exchange programs.
4. MINISTRY OF FOREIGN AFFAIRS
MINISTRY OF EDUCATION OF THE PRC
State Administration of Foreign Affairs Experts
Provincial Ministry of Education
Education Zones Established by Province
5. China, Product Safety and Duke’s Role
1. Duke Kunshan University (DKU)
The big-bet long-term play
Management, technical and
liberal arts education
2. CREATe
Duke Clinical Research Institute + UL
EduNeering
online compliance training
3. Safety at the Source
Duke CE custom courses for
toy industry’s Chinese suppliers
wendy.kuran@duke.edu
6.
7. The “Hardware”: DKU Campus–Phase I
– 200 acre site within
1,700 acre Kunshan
Yangcheng Lake
Science Park
Conference Center
– Six buildings Phase
Academic Center I, 750,000 Sq. Ft
– Phase I construction
paid by Kunshan
– Duke investment in
master plan, building
design, and
Research Center construction oversight
– First five buildings
ready in 2014
8. The “Software”: Degree and Non-degree Programs
Program Development--Phase I
(Targeting Fall 2014)
Research Centers
Global Health
Entrepreneurship
Undergraduate Chinese Enterprises
Others
Semesters
Liberal Arts/Languages
Global Health
Entrepreneurship & Innovation
Neuroscience
Others
Graduate Degrees
Management Studies
Executive Global Health
Clinical Informatics
Education & Medical Physics
Conferences Others
(Begin early 2014)
9. “Fusion Education”
• Best of Chinese and Western Education
• Students from China, U.S. and other parts of the world
• Hard working, inquisitive, versatile, innovative
• Using their intelligence for the social good
• Creative problem solvers with global
perspective and imagination
10. Clinical Research Education and
Training
Ensure patient safety, good data quality, and ultimately, a thorough
understanding of drug efficacy and safety
Thought leadership in
Pioneers in technology-
enabled knowledge
clinical research and Duke Clinical UL delivery solutions
education Research
Institute
Ethical and
Effective Clinical
Research
Ecosystem
Drivers of the
drug, biologics, and Industry Clinical
Partners Research Sites Core participants in the
device development
conduct of clinical trials
process
11. An Educational Solution to:
Ethical Issues Scientific Issues Resource/Financial
Only 18% of researchers Drugs may react differently
Issues
appropriately informed in treatment naïve High turnover of human
participants about the population in emerging capital leads to costly data
study before enrollment regions quality issues
Acute need to replicate
scientific rigor and ethical oversight standards
at all research sites
12. Mandarin Education Modules
and Beyond
Clinical Research Communication & Registry of Trained
Education Collaboration Portal Researchers & Sites
• Self-paced • Portal as a • Data on
comprehensive communication tool investigators and
education program for sponsors qualifications
• Training for • Sites access custom • Information on sites
conducting FDA information and potential study
and EMEA populations
compliant studies • Forum for
networking and • Clean, up-to-date
• Customized to knowledge data that can
local regulatory exchange facilitate recruitment
requirements
13. China Clients
1. SASAC:
CEOs of State-Owned
Enterprises in USA
CEOs in Beijing
2. Roche Diagnostics
Director Program in China
Manager Program in China
3. Essence Securities
13
14. Safety at the Source Opportunity
The Problem: Importers from China sometimes face
expensive delays and even recalls due to product
specifications and safety standards not being met
by the supplier and their extended supply chain.
A Solution: A group of importers and Duke are
working together to design short “Safety at the
Source” workshops for Chinese manufacturers, to
be delivered in China at Duke’s Kunshan campus by
Duke CE’s Mandarin-speaking educators.
15. Safety at the Source Topics
• Analytical tools and skills that can be used to solve
supply chain problems
• Techniques to flag importer’s faulty designs and risky
timelines
• Process control protocols, so that testing and quality
control catch the products that fail to meet export
safety standards
• Pre-work to the 3-day workshop: CPSC standards that
are translated and online and review basics. Must pass
Duke CE test to receive Certificate of Completion.
16. Dean W. Woodard
Director
Office of Education, Global Outreach, and Small Business
Ombudsman (EXGO)
dwoodard@cpsc.gov
(301) 504-7651
business@cpsc.gov
(301) 504-7999
Join the EXGO list serve Desktop Reference
for regular updates. Just Guide
send Dean an email. www.cpsc.gov/desktopguide
Slideshare Twitter
Downloadable Presentations Frequent Updates
www.SlideShare.net/USCPSC @CPSCSmallBiz
Notas del editor
Interlocking nature of the systemThe essential transaction of a site is between a research subject and an investigator
to get Safety at Source off the ground. These funds would be invested over four-six months in the following manner:I. Design: to finance needs-based interviews with all players identified above: Chinese manufacturers and Toy Associations, Importers, Retailers, Chinese-based testers and agents. Identify what education initiatives are already underway. The result would be a Discovery Report that identifies the primary needs2. Curriculum development that meets the manufacturers’ needs, so the workshops are as practical and relevant as possible. Identifying and working with Duke CE mandarin-speaking educators to create the curriculum. Obtaining Steering Committee input to content thru Draft and Final design document checks.3. First 2 cohorts. Identifying which companies will send 3-4 senior managers to comprise the first two cohorts of 30-40 participants.A first workshop could be launched six months from finalization of the Steering Committee $110,000 investments being obtained.Benefits to Steering Committee Membership:Reduce the risk and cost of poorly manufactured products that do not meet CPSC’s standardsReflect publicly an investment in China, in your supply channels and in your product safety (a CSR statement in USA; a nation-building statement in China)Include two participants to the first two workshops free of chargeInfluence the content as a way to ensure its relevance to your suppliers and product needs
to get Safety at Source off the ground. These funds would be invested over four-six months in the following manner:I. Design: to finance needs-based interviews with all players identified above: Chinese manufacturers and Toy Associations, Importers, Retailers, Chinese-based testers and agents. Identify what education initiatives are already underway. The result would be a Discovery Report that identifies the primary needs2. Curriculum development that meets the manufacturers’ needs, so the workshops are as practical and relevant as possible. Identifying and working with Duke CE mandarin-speaking educators to create the curriculum. Obtaining Steering Committee input to content thru Draft and Final design document checks.3. First 2 cohorts. Identifying which companies will send 3-4 senior managers to comprise the first two cohorts of 30-40 participants.A first workshop could be launched six months from finalization of the Steering Committee $110,000 investments being obtained.Benefits to Steering Committee Membership:Reduce the risk and cost of poorly manufactured products that do not meet CPSC’s standardsReflect publicly an investment in China, in your supply channels and in your product safety (a CSR statement in USA; a nation-building statement in China)Include two participants to the first two workshops free of chargeInfluence the content as a way to ensure its relevance to your suppliers and product needs