One-Day Training Course of USC for the Development of Sino-American Collaboration in ...

One-Day
Training Course of USC for the Development of Sino-American Collaboration in
the Healthcare Industry: FDA Regaulations, Medical Device, Biologics,Clinical Trials, OTCs and Food, and Outsourcing Partnership

September 19th, 2011,Monday
Zhongshan Hospital Fudan University,
Shanghai, China

Hosted by:
University of South California
Shanghai Xuhui Fenglin Life Science Park
Shanghai Clinical Research Center
Juke Biotech Park

Organized by:
Shanghai Xuhui Fenglin Life Science Park
Green World Public Relation & Consultant (Beijing)Co.,Ltd.

Supported by:
China Center for Pharmaceutical International Exchange
Chinese Journal of New Drugs and Clinical Remendies
Zhongshan Hospital Fudan University

http:///2011USCEDU/

Welcome from the Chair

We are looking forward to participating as cosponsors and speakers in the upcoming shortcourse, titled ”One -Day Training Course of USC for the Development of Sino- American Collaboration in the Healthcare Industry: FDA Regulations, Medical Device, Biologics, Clinical Trials, OTCs and Food, and Outsourcing Partnership.” It is a unique opportunity to bring together regulatory and quality experts from the Unites States to discuss the current state of regulations related to foods, dietary supplements, cosmetics, drugs and medical devices. The short course coincides with the visit of this delegation to Shanghai as part of an educational exchange, so that we also can learn more from you about the caning regulatory and commercial environment in China. All of the participants are working professionals who are at the same time completing doctoral studies in Regulatory Science. This program, the first in the world of this type, allows medical products experts and practitioners to conduct research and improve their practice while employed. We are particularly excited about our first stop in Shanghai, where we have previously visited and have found the city and its industries to be both advanced and innovative.

In the upcoming short course we will have the chance to exchange views and educate each other about the current state and proposed changes on the horizon for the US FDA and other regulatory agencies, at developmental as well as commercial stages.

Frances Richmond, Ph.D.
Director of Regulatory Science Program, School of Pharmacy,
University of Southern California

Agenda September 19th, 2011, Monday Shanghai, China

Morning Session
Chinese-English Simultaneous interpretation

09:00-09:20 Opening Ceremony
09:00-09:10 Chairman Opening Remarks & Brief Introduction of the Speakers and Honored Guests
09:10-09:15 Welcome Speech of Guests from Shanghai Fenglin Life Science Park Office
09:15-09:20 Welcome Speech of Government Leaders from Shanghai Xuhui District

09:20-10:40 Plenary Session: Regulation,Marketing Access and the Opportunities for Collaboration, Part I

09:20-10:00 Import & Export Regulations
Patrick Dimapindan,DRSc student, Regulatory Science Program, USC
10:00 -10:40 The US Regulatory System:An Update
Frances Richmond, PhD, Director of Regulatory Science Program, School of Pharmacy, University of Southern California

10:40-10:50 Break Time

10:50-11:20 Plenary Session: Regulation,Marketing Access and the Opportunities for Collaboration,Part II

10:50-11:20 Meeting FDA Quality Standards
Chin-Wei Soo, M.S., RAC, DRSc student, Regulatory Science Program, USC, Principal Regulatory Affairs Specialist for edtronic
11:20-11:50 Preparing for FDA Inspection
Clare Elser, DRSc student, Regulatory Science Program, USC, Senior Site Auditor, Merck Sharp & Dohme
11:50-12:00 Questions and Answers
12:00-12:10 Group Photography

12:10-13:00 Lunch and Break

Afternoon Session
Chinese-English Consecutive Interpretation

13:00-16:10 Panel Session I: Medical Device
13:00-13:50 The 510 K Submission Processes / Recent Evolution of the 510 K Clearance
Kobby Dankwah, MS, RAC, CQE, CRE, CQA, DRSc student, Regulatory
Science Program, USC, Divisional Vice President, Abbott Diabetes Care
13:50-14:40 FDA's Oversight of Software and Electronic System
Haven McCall, MS DRSc student, Regulatory Science Program, USC, Quality
Assurance / Regulatory Affairs, GE Healthcare IT

14:40-14:50 Break Time
14:50-15:40 Medical Device Regulations

13:00-16:10 Panel Session II: Biologics
13:00-13:50 Regulatory Submissions for Biologics
Neal Storm, MSc, MBA, RAC, DRSc student, Regulatory Science Program,
USC, Senior Manager, Global Regulatory Affairs, Amgen Inc.
13:50-14:40 US Regulations for Stem Cells
Mauricio S. Umaña, M.Sc. DRSc student, Regulatory Science Program, USC,
Product Manager, National Institutes of Health

14:40-14:50 Break Time
14:50-15:40 Considerations of Outsourcing
Isara Isarowong MBA, CQA, DRSc student, Regulatory Science Program, USC,
Senior Manager, Allergan Incorporated
15:40-16:10 Question & Answer

13:00-16:10 Panel Session III: Food and OTCs
13:00-13:50 Regulatory Expectations of Cosmetics / US Regulation of Dietary Supplements
Simone E. Turnbull, MS, DRSc student, Regulatory Science Program, USC,
Regulatory Analyst, Amway-Nutrilite

13:50-14:40 New Initiatives in Food Regulations
Lilit Aladadyan, MPH, DRSc student, Regulatory Science Program, USC,
Director of Health Education Glendale Healthy Kids

14:40-14:50 Break Time
14:50-15:40 Regulatory Expectations for OTCs
Valerie Ramsey, MS, RAC, DRSc student, Regulatory Science Program,
USC, Director, Global Regulatory Affairs, Fleet Laboratories
15:40-16:10 Question & Answer

13:00-16:10 Panel Session IV: Drug Clinical Trial
13:00-13:50 Multi-Regional Clinical Trials (MRCT) and their challenges/associated considerations
Hesham A. Abdullah, MD, DRSc student, Regulatory Science Program, USC, Associate
Director of Global Regulatory Affairs, MedImmune, LLC, AstraZeneca, PLC
13:50-14:40 Animal Trials under GLPs
David M. Locke, M.S. DRSc student, Regulatory Science Program, USC,
Product Compliance Liaison, Ethicon Endo-Surgery In, Johnson and Johnson

14:40-14:50 Break Time

14:50-15:40 Clinical Trial Management
JoAnn P Pfeiffer, M.S., CCRA, RAC, DRSc student, Regulatory Science Program,
USC, Director of Product Management, Velos, Inc.

15:40-16:10 Question& Answer

16:10-16:15 Closing Ceremony
Gerald E. Loeb, MD, Professor of Biomedical Engineering Director of
the Medical Device Development Facility, USC

15:40-16:10 Question & Answer

Participants may come from

- Biomedical R & D, Manufacturing Enterprises
- Medical Device R & D, Manufacturing Enterprises
- OTC Manufacturers
- Health Care Products, Health Food, Dietary Supplement Manufacturers
- CRO & CMO Services
- Clinical Pharmacology Center
- Institutions and Research Organizations
- Industry, Academic Organizations
- Registration, Intellectual Property, Legal, Marketing, Investment and Consulting Services
- Industrial Parks and Government Science and Technology, Industry, Business Promotion Agencies

Departments

Registration, Regulation, Government Affairs,Research and Business Development

University of Southern California is one of the world’s leading private research
universities. An anchor institution in Los Angeles, a global center for arts, technology and international trade, USC enrolls more international students than any other U.S. university and offers extensive opportunities for internships and study abroad. With a strong tradition of integrating liberal and professional
education, USC fosters a vibrant culture of public service and encourages students
to cross academic as well as geographic boundaries in their pursuit of knowledge.

Xuhui Fenglin life science park that consists of Eeastern Fenglin Region and
Western Caohejing development zone is one of the six industrial base of Shanghai
life science industry. Based on abandunt resources in life science and strong historical culture, powered by innovations,featured by research outsourcing, consisted of innovative manufacture, research services and pharmaceutical business, Xuhui is going to establish the functional development industrial cluster in life science area. Now pattern of Xuhui will be formed by taking advantage of
the characteristic of Eastern Fenlin region and Western Caohejing development zone.

Registration Fees & Discounts

※ Industry Representatives: RMB1600.00
※ Academic, Organizations and Government Representatives: RMB1200.00
※ Student Representative: RMB800.00

Preferential policies:
※ 10% discount with online registration;
※ 4 registrations from the same company/organization, an additional one will be free;
※ 40% discount for special representatives from Fenglin Life Science Park;
※ The above favorable terms may be double counted.

Registration Fees & Discounts

GreenWord Public Relations & Consultant (Beijing) Co., Ltd.

Address: Rm. 1117, Block A, ShiAo InternationalCenter,
No.101,Shaoyaoju Beili,
Chaoyang District, Beijing, China 100029

Tel.: +86-10- 84351699 Ext. 8003、8005 Fax: 86-10-64915913
Contact Person: Joanna Liang: ae@aceshow.cn   (mobile: 13552215186);
Chenxuan Wu: wuchenxuan@gw-bj.com  (mobile:15104573038)