多年來(lái),亞洲日益成為全球臨床研究的溫床和目的地。一方面,越來(lái)越多的全球制藥公司已經(jīng)認(rèn)識(shí)到將亞洲融入全球早期和晚期臨床開(kāi)發(fā)階段的重要性和優(yōu)勢(shì)，同時(shí)亞洲臨床研究市場(chǎng)被迅速改變的亞洲本地研發(fā)創(chuàng)新進(jìn)一步推動(dòng)和促進(jìn)。

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【會(huì)議背景】：做為我們非常成功的臨床試驗(yàn)峰會(huì)系列的一部分,本次峰會(huì)由Pan Asian Clinical Research Asociation,SAPA, Society for Clinical Trials協(xié)會(huì)共同支持，將在2015年12月3日和4日在上海博雅大酒店舉辦。

屆時(shí)將吸引超過(guò)180位臨床研發(fā)領(lǐng)域的企業(yè)高層管理者參與，80%的參會(huì)者為總監(jiān)級(jí)別以上職位。絕大多數(shù)參會(huì)者來(lái)自跨國(guó)或本土的制藥企業(yè)、生物技術(shù)公司及醫(yī)療器械企業(yè)。相關(guān)政府官員、大學(xué)教授及中國(guó)頂級(jí)醫(yī)院的研究者每年也競(jìng)相參與本會(huì)議。

尋求新的商業(yè)合作機(jī)會(huì)并與行業(yè)同行們交流學(xué)習(xí)如何解決當(dāng)前行業(yè)熱點(diǎn)問(wèn)題及挑戰(zhàn)，如臨床合作和外包策略;?亞洲監(jiān)管變革和市場(chǎng)準(zhǔn)入;臨床合作與技術(shù)創(chuàng)新，在臨床運(yùn)營(yíng)中的最佳實(shí)踐技術(shù)與項(xiàng)目管理;數(shù)據(jù)收集、質(zhì)量與風(fēng)險(xiǎn)管理;并解決知識(shí)產(chǎn)權(quán)如何保護(hù),藥物安全,透明度和質(zhì)量以及物流供應(yīng)鏈等問(wèn)題,保持和更新臨床試驗(yàn)在該地區(qū)的增長(zhǎng)速度與繁榮。

如果您期望與亞洲臨床研發(fā)領(lǐng)域的決策者們會(huì)面及交流學(xué)習(xí)，這里將是您唯一正確的選擇。令您及您的團(tuán)隊(duì)始終處于亞洲臨床研究發(fā)展最前沿，盡在2015年12月3-4日的Asia Clinical Trials Leaders?年會(huì)，期待您的參與!

屆時(shí)峰會(huì)將有國(guó)際主題演講，產(chǎn)業(yè)及學(xué)術(shù)報(bào)告，眾多交流機(jī)會(huì)，將為高端科技及商業(yè)探討打造一個(gè)互動(dòng)的平臺(tái)。

【會(huì)議名稱】：2015亞洲臨床試驗(yàn)領(lǐng)袖峰會(huì)

【會(huì)議時(shí)間】：2015年12月3至4日

【會(huì)議地點(diǎn)】：上海博雅大酒店

【主辦單位】：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