多年来,亚洲日益成为全球临床研究的温床和目的地。一方面,越来越多的全球制药公司已经认识到将亚洲融入全球早期和晚期临床开发阶段的重要性和优势，同时亚洲临床研究市场被迅速改变的亚洲本地研发创新进一步推动和促进。

【会议背景】：做为我们非常成功的临床试验峰会系列的一部分,本次峰会由Pan Asian Clinical Research Asociation,SAPA, Society for Clinical Trials协会共同支持，将在2015年12月3日和4日在上海博雅大酒店举办。

届时将吸引超过180位临床研发领域的企业高层管理者参与，80%的参会者为总监级别以上职位。绝大多数参会者来自跨国或本土的制药企业、生物技术公司及医疗器械企业。相关政府官员、大学教授及中国顶级医院的研究者每年也竞相参与本会议。

寻求新的商业合作机会并与行业同行们交流学习如何解决当前行业热点问题及挑战，如临床合作和外包策略; 亚洲监管变革和市场准入;临床合作与技术创新，在临床运营中的最佳实践技术与项目管理;数据收集、质量与风险管理;并解决知识产权如何保护,药物安全,透明度和质量以及物流供应链等问题,保持和更新临床试验在该地区的增长速度与繁荣。

如果您期望与亚洲临床研发领域的决策者们会面及交流学习，这里将是您唯一正确的选择。令您及您的团队始终处于亚洲临床研究发展最前沿，尽在2015年12月3-4日的Asia Clinical Trials Leaders 年会，期待您的参与!

届时峰会将有国际主题演讲，产业及学术报告，众多交流机会，将为高端科技及商业探讨打造一个互动的平台。

【会议名称】：2015亚洲临床试验领袖峰会

【会议时间】：2015年12月3至4日

【会议地点】：上海博雅大酒店

【主办单位】：WBF Group&PACRA

Day One December3,Thursday

0800 Registration&Coffee

0900 What are the Key Commercial Considerations for Successful Drug Development and Investment in Asia?

•Competitive outlook for the Asian pharmaceutical sector: Diversify or focus on core segments?

•Commercial challenges, issues and potential solutions for successful drug development in Asia

•Examining the Asian R&D and commercial pathway for a big pharma

•Incorporating changes in big pharma organizational structures for the integration of Asia R&D

•Establishing central trial coordination operating models for the Asia-Pacific R&D trial portfolio

•Exploring collaboration models in Asia for successful drug development

•Commercial and market challenges for profitable drug development and portfolio development in Asia

Moderator: 

John Choi, Chief Business Officer, Hua Medicine 

Panelists: 

Min Irwin,VP, head of China Medicine Development, 

GLAXOSMITHKLINE 

Dennis Wong, Associate VP, Head of Clinical Development, AP R&D, Sanofi

0930Successful Stories of Bringing / Developing Innovative Products in China 

• Defining Innovation and Innovative Pharmaceutical Products 

•Pathways for Development (Create from Scratch, In-license, Partner with China company for Development) 

• Examples of different approaches & Lessons 

• Case Study (Hua Medicine’s in-licensing of 4th Generation GKA asset from Roche) John Choi, Chief Business Officer, Hua Medicine 

1000 Biologics Development in Asia Dennis Wong,Associate VP, Head of Clinical Development, AP R&D,Sanofi

1030 Tea and Break 

1100 Recruitment 2016---Attracting and Retaining Key People in the Year Ahead 

Matthew Bulley,Director Asia Pacific, Barrington James

1130 Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients 

•Four-way relationship between sponsors, sites, CROs & patients - Realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution 

•Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges? 

•Choosing a partner who can take necessary steps to rectify the situation when things go wrong 

•Understanding sponsors principle for selecting the local clinical research organization 

•Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction 

•What are the current perspectives on the future of outsourcing in Asia?

Moderator: 

Shaojing Hu, VP & Chief Chemist, Betta Pharmaceuticals 

Panellists: 

Beat E. Widler, Managing Partner, Widler & Schiemann AG Robbie Chana, VP, Business Development – Europe & Asia Pacific, Bioclinica 

1200 Networking & Luncheon

1400 Bridging Gaps in Meeting Trial Timelines: Effective Communication Between Biometrics and Clinical Trial Operations 

•Ensuring data quality within given timelines 

•Need for effective communication between Biometrics and Clinical Operation teams 

•Establish the right teams to speed up trial timelines 

Dejun Tang, Site Head, Biometrics & Statistical Sciences and Methodology, Novartis Pharma China

1430New Drug Review Initiatives to Encourage Innovations by CFDA & global collaboration can do more Shaojing Hu, VP & Chief Chemist, Betta Pharmaceuticals 

1500 ICH GCP Revision: what is new, how may the revision impact the way we do clinical trials? 

Beat E. Widler,Managing Partner,Widler & Schiemann AG 1530Tea and Break 

1600 Conference Adjourn

Day Two December4,Friday

0800 Registration&Coffee 

0900 Innovative Approaches to Clinical Partnering 

• Case examples of different kinds of partnerships in clinical trials (eg. academia/pharma; pharma/pharma; pharma/CRO & more) 

• Determining pros and cons of partnering with local vs. global SMOs & CROs 

• Maintaining relationship and generating good quality supporting protocols

Moderator: 

Fangning Zhang, Partner , Greater China Office, Shanghai , 

McKinsey & Company 

Panelists: 

Shuling Wu, Associate Director, Data Management TA Lead, Pfizer (China) Research & Development 

Rebecca Wang, Executive Medical Director ; Global Regulatory Affairs and Safety; Bone Safety TA Head, Amgen 

David Yang,CEO,Microconstant

0930 Risk Based Safety Management in Clinical Trials Risk based safety management (RBSM) in clinical trials is widely credited for protecting human subjects during a clinical trial and ensuring integrity of study. Although the process of RBSM various significantly among pharmaceutical companies, the common elements include (1) commit to protect human subjects and integrity of safety information in the clinical trials – the organisational culture ensures that all the members of the organization give priority to patient safety; (2) understand hazards and evaluate risk – the foundation of a risk-based approach; (3) manage risk – the ongoing execution of RBSM; and (4) evaluation of effectiveness of RBSM system - learn from experience via metrics, incidents, audits and management reviews, provide direct feedback on the workings of the system, and improve it.

Rebecca Wang, Executive Medical Director ; Global Regulatory Affairs and Safety; Bone Safety TA Head, Amgen

1000Evaluating China as the Data Management Center for Global Projects

Wei Zhang, Associate Director, Data Management TA Lead, Pfizer (China) Research & Development

1030 Tea and Break

1100 The China effect on innovation and implications to pharma

China spent more than $200 billionon research and development in 2014, the second-largest investment by any country inabsolute terms (and about 2 percent of GDP). Its universities graduate more than 1.2 millionengineers each year—more than the next five countries combined. But how innovative is the Chinese economy? Does China have the innovative capacity to raiseproductivity, create more high value-added jobs, and achieve its economic aspirations?

Within pharma, China has significantly increased R&D spending, established multiple industry parks, attracted thousands of oversea returnees who bring years of industry experiences. But will China become a global leader on pharma innovation? What does it take to get there? Fangning Zhang, Partner , Greater China Office, Shanghai , McKinsey & Company

1130 Caveats in analyzing observational data – Examples and practice

In clinical development, after the drug is on the market, data collection usually switches to post-marketing studies, or real-world surveillance. Due to lack of comparator, lack of rigor in study set-up, the translation validity from data to information is often in question. Confounding is almost always an issue. Most of the literature simply ignores confounding,and most of the rest attempts to control confounding improperly. I will summarize common problems in data interpretation in this area, and use examples to show how we as an industry can do a better job in extracting real information. Ouhong Wang, Head of Biostatistics & Programming, China, Amgen

1230 Networking & Luncheon

1400 From a GCP Office to a Real SMO: A Data Quality

Perspective

Henry Yau, Managing Director and Honorary Assistant Professor of The University of Hong Kong Clinical Trials Centre

1430 e-Clinical Technology in China

Information Technology has been greatly implemented in clinical research from data processing and randomization. This presentation will cover

•Current status of e-clinical in China

•Challeges global pharma experienced

•Oppertunities for local Pharma

Hualong Sun, General manager, Meta Clinical Technology

1500 Tea and Break

1530 Conference Adjourn

3000元/位