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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.
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
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.
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
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
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
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)
“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
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
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
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
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
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.
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.
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

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ICPHSO International Education

  • 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

Notes de l'éditeur

  1. Interlocking nature of the systemThe essential transaction of a site is between a research subject and an investigator
  2. 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
  3. 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