Agenda at a Glance

議程介紹

主要會議中有同步翻譯

Pre-conference workshop：2011年10月12日(星期三)
研究會在9：00～12：30，1：30～4：30舉辦，上午和下午之間各有休息時間。參加整日者（上午及下午的研究會）有提供午餐。在各會議30分鐘前開始登記。請從下面的選項選擇主題。
A: 癌治療效驗的最適化：為縮短亞洲癌治療藥開發期間的策略 LED BY: Melvin Toh, Vice President Pharma Development, CK Life Sciences, Hong Kong Matthew J. Bryant, Sr. Manager, Oncology Asia Pacific Clinical Project Management, DCOE AP - Eli Lilly Japan Emily Tan, Executive Director, Pharmanet
B: 改善亞洲之策略上的合作 LED BY: Nadina C Jose, Regional Director, Global Clinical Site Management and Monitoring Asia-Pacific, Allergan Roshan Padbidri, SM, Clinical Operations, Takeda Global Research & Development Center (Asia) Rupesh Patki, PhD, Regional Area Manager-Asia, Allergan Chris Albani, Managing Director, PRTM
C: 與日本合作有關治療的效驗 Part I: Regulatory Overview of Japan Part II: Operational/Clinical Development Strategies for working with Japan Part III: Cultural Considerations of Doing Business with Japan LED BY: Yutaka Natsumeda, Director of Office of Clinical Trials, Yokohama City University Hospital Hiroshi Sugii, Vice President Clinical Development, Novo Nordisk Tadashi Fujisawa, Chief Executive Officer, Mebiopharm
D: 治療效驗材料供應鏈管理及流通 Part I: Risk Mitigation Techniques for a Global Economy Part II: Building Effective Drug Distribution Networks in Asia Part III: Best Practices for Working with Central Labs Part IV: Dealing wtih Customs: Overcoming Import/Export Obstacles IP Handling
主要會議第1天：2011年10月13日（星期四）
9:00AM	Chairperson's Opening Remarks R Stephen Porter, CEO, VDDI Pharmaceuticals
9:15AM	New Business Opportunities in Clinical Development in Asia Ling Su, PhD, Senior Vice President and Head of Development, Greater China, Novartis Pharmaceuticals Corporation
9:45AM	CRO PERSPECTIVE: Considerations for Inclusion of Asia into Global Drug Development Strategies John Hubbard, SVP Worldwide Drug Development, Pfizer
10:15AM	PHARMA PERSPECTIVE: Integrating China into the Global Drug Development Strategy Emily Tan, Executive Director, Pharmanet
10:45AM	Networking Break
11:30AM	Keynote: Innovative Strategies and Partnering Models: What Will Work for You? Shirley Zhao, Managing Director, China, Genzyme
12:00PM	Innovative Strategies for Accessing Clinical Capabilities in Asia – Responding to Challenges in Global Development Environment Carl Firth, Chief Executive Officer, Aslan Pharmaceuticals
12:30PM	PANEL DISCUSSION: Overcome the Biggest Challenges in Partnering for Late Phase Trials James Cai, Vice President for Clinical Development, Atyr Pharma (Moderator) Jimmy Bautista, Regional Medical Director, Eisai Asia Allan Riting Liu, Vice President, Fosun Pharmaceutical
1:10PM	Networking Luncheon

	藥劑開發之創新的合作	治療藥的治療效驗
	Track Chair: Li Ding, Head of Trial Operations-China and Asia Pacific, Clinical Science and Operations, Sanofi-Aventis	Track Chair: Christina Bodurow, PhD, Senior Director, External Sourcing Development Center of Excellence, Eli Lilly
2:10PM	Ensuring Drug Development Success with Your Chinese Partners- Working with Global CROs vs. Local CROs James Tsui, Contracts & Outsourcing, Roche Product Development Asia Pacific, China	CASE STUDY: AstraZeneca's Strategic Use of Clinical Biomarker in Developing Oncology Clinical Trial Programs Fred Zheng, MD, Ph.D. Research Clinical Scientist, AstraZeneca
2:40PM	CASE STUDY: A New Integrated CRO Model for Managing Pharmaceutical Trials in Asia Donald Russell, Senior Director, International Clinical Operations, Eli Lilly & Co	CASE STUDY: CNS Clinical Trials in Asia Joan Shen, MD, PhD Senior Medical Director Clinical Research, Primary Care Unit, Pfizer
3:10P	Asia's Driving Innovation in Biopharma Partnering Ross Horsburgh, Vice President, Clinical Development, Nycomed	CASE STUDY: Explore Opportunities in Traditional Chinese Medicine Bradley Marchant, Senior Director, Unit Development Office, Asia-Pacific R&D, Sanofi-Aventis
3:40PM	Networking Break
4:10PM	Overcome Challenges in Setting Up Early Phase Work in Asia Helen Jiang, Head of Clinical Development, Hengrui Pharmaceuticals	CASE STUDY: Chinese Biotech's Clinical Studies for an HIV Fusion Inhibitor Jingzong Qi, Vice President and Birector of Business Development, FusoGen Pharmaceuticals
4:40PM	CEO Keynote Panel: Identifying New Business Opportunities in Biosimilars Drug Development in Asia Chris Chen, Chief Executive Officer, Shanghai Celgen Biopharmaceuticals (Moderator) Scott Liu, Chief Executive Officer, Henlius Biopharma Joe Zhou, Chief Executive Officer, Genor BioPharma
5:20PM	Day One Concludes; Networking Reception in the Exhibit Hall
7:00PM	Shanghai Huangpu River Night Cruise (optional) Enjoy stunning views of Shanghai's famous Bund and Pudong as we sail the Huangpu River. Join our cruise and enjoy a small buffet with drinks and local snacks as you network with your colleagues and current and future business partners!

主要會議第2天：2011年10月14日（星期五）
9:00AM	Chairperson's Recap of Day One Chichang Lee, Executive Director, Simcere Pharmaceuticals
9:15AM	KEYNOTE: SFDA Update on Clinical Safety and Monitoring Guidelines and the Current Regulatory Climate in China Wenmin Du, Executive Director, SFDA

	討論有關品質管理、受驗者安全性及積極的風險評估	THE DISCUSSION DEN 討論有關品質管理、受驗者安全性、及積極的風險評估
9:45AM	Safety Monitoring and Risk Management of Clinical Trials in China Rebecca Wang, Head of Product Safety Operation, Shanghai Roche Pharmaceuticals	Roundtable 1: Standard of Care and Ethical Issues in Clinical Trials Jon Lee, Vice President of Clinical Operations, Cerexa, Inc.
10:15AM	Networking Break
11:00AM	Create a Quality Management GCP System to Ensure Compliance in Asia Xun Chen, Head of Clinical Science and Operations in China, Sanofi-Aventis	Roundtable 2: Is it Feasible to Develop Protocols that Integrate Standards of Practice Globally for Multi-national Clinical Trials? Ann Wang, Vice President of Clinical Operations and Data Management, Human Genome Sciences
11:30AM	Quality Oversight when Outsourcing in Asia: Striking the Right Balance Vance Warren, Senior Study Logistics Manager Translational Medicine Clinical Pharmacology, Daiichi Sankyo Pharma Development Jon Lee, Vice President of Clinical Operations, Cerexa, Inc.	Roundtable 3: Ensure Patient Health During the Entire Lifecycle of a Product from Preclinical to Post-Marketing Darshan Bhatt, MD, M.Phil., Director Clinical Drug Safety, Vanthys Pharmaceutical Development (P) Ltd
12:00PM	Networking Luncheon
	Luncheon Roundtable: Overcome Regulatory Obstacles in China, Korea, India and Taiwan
1:30PM	Leverage the Use of Adaptive Clinical Trial Design to Cut Costs, Boost Operational Efficiency and Reduce Study Timelines Stephen Porter, CEO, VDDI Pharmaceuticals
2:00PM	Keynote Panel- Preparing for the Evolving Landscape of Clinical Research in Asia Ross Horsburgh, Vice President Clinical Development, Nycomed (Moderator) Chichang Lee, Executive Director, Simcere Pharmaceuticals John Hubbard, SVP Global Drug Development, Pfizer Inc (invited) Vincenzo Teneggi, Head of Early Development & Clinical Pharmacology, Asia Pacific, Roche
2:40PM	Networking Break
	擴大會議：討論有關在中國受驗者的募集和確保	DISCUSSION DEN CONTINUED
3:20PM	Matthew J. Bryant, Sr. Manager, Oncology Asia Pacific Clinical Project Management, DCOE AP - Eli Lilly	Roundtable 4: Emerging Countries for Clinical Trials in Asia – Utilizing Academic SMOs to Overcome Challenges Prof Asita de Silva, MBBS, DPhil, Director, Clinical Trials Unit, Faculty of Medicine, University of Kelaniya
4:15PM		Roundtable 5: How does your local Chinese company create a strategy to expand its portfolio globally? Yuqiang Wang, Chief Executive Officer, Magpie Biotech
4:45PM		Roundtable 6: Challenges in Working with Labs: Import/Export of Investigational Drugs
5:15PM	Conference Concludes

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