Outsourcing in Clinical Trials China 2025 </br>2025中国临床试验外包大会

The launch of Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research. </br>中国临床试验外包大会的启动，为您在全球增长最快的临床试验市场之一，提供了一个与临床研究创新前沿接轨的机遇。

3 - 4

September

2025
  • Suzhou, China 中国，苏州
  • Ticketed
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Why attend?

Why attend? 为何参会？

The launch of  Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research. Here’s why you should attend:

“中国临床试验外包大会” 为您提供与全球增长最快的临床研究市场创新前沿接轨的机遇。以下是您不容错过的理由：

Access Local Expertise: Gain insights into the unique challenges and opportunities within China’s clinical trials landscape, directly from local and international experts.

获取本土洞见
直击中国临床试验生态的独特挑战与机遇，聆听中外专家的第一手经验分享。

 

Regulatory Updates: Stay ahead with the latest regulatory developments and compliance strategies essential for navigating China’s evolving healthcare environment.

掌握法规动态
获取中国快速演变的医疗监管政策最新进展，学习合规策略以规避风险。

Industry Networking: Build meaningful connections with leading CROs, biopharmaceutical companies, and other stakeholders driving clinical trial success in China.

拓展行业人脉
与推动中国临床试验成功的CRO龙头企业、生物制药公司及行业决策者建立深度合作。

Strategic Collaboration: Explore strategies to optimize outsourcing partnerships and discover tailored solutions for managing clinical trial operations in a complex, dynamic market.

优化合作战略
探索复杂动态市场中的外包合作模式，定制化临床运营解决方案。

 

Emerging Trends: Delve into cutting-edge technologies and methodologies shaping the future of clinical trials in China, from digital tools to innovative supply chain solutions.

前瞻未来趋势
聚焦数字化工具与创新供应链等前沿技术，洞察中国临床试验的未来形态。

Agenda

  • 3 Sep 2025
  • 4 Sep 2025
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END OF CONFERENCE

8 AM

Registration and refreshments
注册签到 & 茶歇交流

8:30 AM

Chairperson’s opening remarks
主席开幕致辞

8:45 AM

Opening Keynote Panel
开幕主题论坛

The Evolving Clinical Trial Landscape in China: Challenges & Opportunities

China has emerged as a key player in global clinical research, driven by regulatory reforms, a vast patient population, and increasing investments in biotechnology. This panel discussion will provide a comprehensive overview of the current clinical trial landscape in China, examining the challenges, opportunities, and future outlook for sponsors, CROs, and global stakeholders.

  • Current State of Clinical Trials in China; Growth trends and recent developments in the Chinese clinical trial ecosystem, impact of regulatory reforms, including NMPA’s efforts to streamline approvals, China’s role in global multi-regional clinical trials (MRCTs)
  • Challenges Facing Clinical Trials in China; Navigating regulatory complexities, Intellectual property (IP) concerns and data protection in clinical research, Operational challenges: site selection, patient recruitment, and investigator training, Differences in trial execution compared to the U.S. and EU
  • Clinical Trial Supply Chain: Challenges and Best Practice; Strategies for reducing supply chain disruptions and ensuring compliance
  • Opportunities for Sponsors & CROs

The Future of Clinical Trials in China; How China is positioning itself as a leader in global drug development. Potential impact of geopolitical factors on international collaboration

 

中国临床试验格局的演变：挑战与机遇

中国凭借监管改革、庞大的患者群体及对生物技术日益增长的投资，已成为全球临床研究的关键参与者。本论坛将全面剖析中国临床试验的现状，探讨申办方、CRO及全球利益相关方面临的挑战、机遇与未来前景。

  • 中国临床试验现状：中国临床试验生态系统的增长趋势与最新进展；监管改革的影响（包括NMPA审批流程优化举措）；中国在全球多区域临床试验（MRCT）中的角色
  • 中国临床试验面临的挑战：复杂监管环境的应对策略；知识产权保护与临床研究数据安全；实操难点：研究中心筛选、患者招募及研究者培训；中美欧临床试验执行的差异性分析
  • 临床试验供应链：挑战与最佳实践
  • 降低供应链中断风险与合规保障策略
  • 赞助商与CRO的机遇

中国临床试验的未来图景：中国如何确立全球药物研发领导地位；地缘政治因素对国际合作的潜在影响

9:30 AM

Reserved for Event Sponsor
赞助商专场

10 AM

Global Relationships: Enhancing Collaboration in Outsourcing
全球合作：加强外包协作关系

  • Working with Chinese CROs and CMOs – what global sponsors should know
  • Managing cross-border clinical trials: logistics, communication, and cultural considerations
  • Case studies of successful global-China partnerships
  • 与全球CRO/CMO合作——中国企业必备指南
  • 跨国临床试验管理要点：物流协调、沟通机制与文化适配
  • 中外合作成功案例深度解析

10:30 AM

Reserved for Event Sponsor
赞助商专场

11 AM

Morning refreshments and networking – Please visit 3 booths in this break
上午茶歇与交流互动——请在此期间至少参观3个展位

STREAM A: Outsourcing & Clinical Operations

11:30 AM

Clinical Operations: Optimizing Efficiency in China
临床运营：提升中国区执行效能

  • Site selection strategies and patient recruitment challenges
  • Decentralized trials and remote monitoring in China
  • Risk management and quality control in outsourced trials

 

  • 研究中心筛选策略与患者招募挑战
  • 中国本土去中心化临床试验与远程监查实践
  • 外包试验中的风险管理与质量控制

12 PM

Reserved for event Sponsor
赞助商专场

12:30 PM

Implementing Artificial Intelligence in Drug Discovery and Development in China
人工智能（AI）在中国药物研发中的应用实践

China is rapidly integrating artificial intelligence (AI) into drug discovery and clinical development, driven by advancements in machine learning, big data analytics, and government support for biotech innovation. This session will focus on the practical implementation of AI, from early-stage discovery to regulatory submission, and discuss how companies can successfully leverage AI while navigating China’s evolving regulatory landscape.

• AI integration across the drug development lifecycle
• Building AI-driven drug discovery pipelines in China
• Regulatory and compliance consideration for AI implementation
• Overcoming challenges in AI adoption

 

中国正快速将人工智能（AI）整合到药物研发和临床开发中，这得益于机器学习、大数据分析的进步以及政府对生物技术创新的支持。本环节将聚焦AI从早期发现到监管申报的实际应用，并探讨企业如何在不断变化的中国监管环境中成功利用AI技术。

• AI在药物研发全生命周期中的整合
• 构建AI驱动的中国药物研发管线
• AI应用的监管与合规考量
• AI技术落地面临的挑战与应对

1 PM

Lunch and networking – Please visit 3 booths in this break
午餐交流时间——请在此期间参观至少3个展位

2:15 PM

Panel Innovation in Technology: Transforming Clinical Trials

  • AI and big data in clinical trial design and execution
  • Digital platforms for patient recruitment and engagement
  • Dissecting the challenges surrounding PIPL and how to overcome them

科技创新：重塑临床试验格局

• 人工智能与大数据在临床试验设计与执行中的应用
• 数字化平台赋能患者招募与参与
• 解析《个人信息保护法》(PIPL)相关挑战及应对策略

2:45 PM

Reserved for Event Sponsor
赞助商专场

3:15 PM

Navigating Licensing & Regulatory Frameworks in China
中国许可与监管框架的应对策略

  • Updates on China’s National Medical Products Administration (NMPA) regulations
  • Recent reforms in drug and device approval processes
  • Best practices for obtaining IND and NDA approvals in China

 

  • 中国国家药品监督管理局（NMPA）法规更新
  • 药品和医疗器械审批流程的最新改革
  • 在中国获得IND（新药临床试验申请）和NDA（新药上市申请）批准的最佳实践

3:45 PM

Afternoon refreshments and networking – Please visit 3 booths in this break
下午茶歇与交流时间——请在此期间参观至少3个展位

4:30 PM

Regulatory Harmonization: Bridging China and Global Markets
监管协调：连接中国与全球市场

  • Aligning with FDA, EMA, and NMPA requirements
  • Strategies for multinational trials involving China
  • Understanding China’s role in global drug development

 

  • 满足FDA（美国食品药品监督管理局）、EMA（欧洲药品管理局）与NMPA（中国国家药品监督管理局）的协同要求
  • 中国参与跨国临床试验的策略部署
  • 解读中国在全球药物研发中的战略定位

5 PM

PANEL DISCUSSION: The Future of Outsourcing in China: Trends and Predictions
专题讨论：中国临床试验外包的未来趋势与展望

  • AI-driven trial forecasting and automation
  • Evolving business models in clinical outsourcing
  • The impact of China’s biotech boom on global trials

 

  • 人工智能驱动的试验预测与自动化
  • 临床外包业务模式的创新演进
  • 中国生物科技热潮对全球试验的影响

5:30 PM

Chairperson’s closing remarks
大会主席总结致辞

8:30 AM

Registration and refreshments
注册签到与茶歇交流

9:10 AM

Chairperson’s opening remarks
主席开幕致辞

STREAM A: Outsourcing & Clinical Operations

9:15 AM

Patient Centricity in Clinical Trials: A New Era in China
以患者为中心的临床试验：中国新时代

As China’s clinical trial ecosystem evolves, there is a growing emphasis on patient-centric approaches to improve recruitment, retention, and overall trial outcomes. This session will explore strategies to enhance patient engagement, leverage digital health solutions, and address cultural and regulatory considerations for patient-centric clinical trials in China.

  • Understanding the Shift Toward Patient- Centric Trials in China
  • Enhancing Patient Recruitment and Retention
  • Digital Health and Remote Monitoring in Patient-Centric Trials

Regulatory and Ethical Considerations

 

随着中国临床试验生态系统的演进，聚焦患者需求的模式正显著提升受试者招募、留存及整体试验质量。本环节将探讨如何通过数字化健康解决方案增强患者参与度，并解析中国患者中心式试验中的文化适应性与监管要求。

  • 中国患者中心化临床试验转型趋势解读
  • 创新患者招募与留存策略
  • 数字医疗与远程监测技术在患者中心化试验中的应用
  • 特殊监管要求与伦理考量

9:45 AM

Reserved for Event Sponsor
赞助商专场

10:15 AM

Vendor Selection Strategies: Building knowledge for optimal decision-making
供应商优选策略：科学决策方法论

  • Understanding the vendor landscape, best practice and key considerations
  • Key considerations for vendor selection
  • Vendor evaluation and due diligence

 

  • 全面认知供应商生态：行业实践与核心评估维度
  • 供应商筛选关键指标矩阵
  • 供应商能力评估与尽职调查规范
  • 战略合作伙伴关系维护机制

10:45 AM

Morning refreshments and networking – Please visit 3 booths in this break
上午茶歇与交流互动——请在此期间至少参观3个展位

11:45 AM

Reserved for Event Sponsor
赞助商专场

12:15 PM

PANEL DISCUSSION
专题讨论

The Clinical Trial Landscape for Small to Mid- Sized Biopharma in China

  • New regulations and guidance around clinical trials in China: how will this impact you?
  • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company

An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

 

中小型生物制药企业在华临床试验发展路径

  • 中国临床试验新规解读：对中小型企业的实际影响
  • 动态变化的CRO/供应商生态应对策略
  • 临床试验技术创新应用评估：有效方案与现存瓶颈

3:30 PM

Speaker Hosted Roundtables
嘉宾主持圆桌讨论会

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Roundtable session lasts for 30 minutes and rotate

ROUNDTABLE 1: What key aspects of inspection readiness should be considered right now?
ROUNDTABLE 2: Getting the best out of your sponsor – CRO partnership
ROUNDTABLE 3: Ensuring clinical quality assurance in supply chain management

 

互动式圆桌会议为您提供与同行深入交流的独特机会，共同探讨行业关键挑战的解决方案并分享最佳实践。每场讨论由行业专家主持，聚焦单一议题，通过高互动形式拓展人脉网络，汲取他人经验智慧。
（每场圆桌讨论时长30分钟，参会者可轮换参与）

圆桌议题1：当前核查准备工作的核心要素
圆桌议题2：如何构建最优申办方-CRO合作伙伴关系
圆桌议题3：临床试验供应链质量管理保障机制

Chairperson’s closing remarks
大会总结致辞与抽奖环节 参与即有机会赢取科技产品等丰厚奖品

Join us for a chance to win one of our prizes, including Technology products

会议圆满结束

1 PM

Lunch and networking – Please visit 3 booths in this break
午餐交流时间——请在此期间参观至少3个展位

2:15 PM

PANEL The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
专题讨论

China’s biotech industry has rapidly expanded, posing increasing competition to U.S. biotech firms in drug development, clinical trials, and global market entry. With strong government support, access to capital, and a growing pipeline of innovative therapies, Chinese biotech companies— backed by aggressive venture capital (VC) funding—are reshaping the industry. This session will analyse the competitive landscape, the challenges faced by U.S. biotech firms, and the future dynamics of global biotech innovation.

  • The Rise of China’s Biotech Industry: The Chinese government’s “Made in China 2025” strategy and its impact on biotech innovation
  • The role of China’s National Medical Products Administration (NMPA) in accelerating drug approvals
  • The Role of Venture Capital in China’s Biotech Boom; How Chinese VCs and state-backed funds are fueling biotech startups and the differences between U.S. and Chinese biotech           funding models
  • Competitive Pressure on U.S. Biotech Firms

Regulatory & Geopolitical Challenges: The impact of U.S.-China trade tensions and export       controls on biotech collaboration

 

中国生物科技崛起：美国企业与投资者的竞争挑战

中国生物科技产业迅猛发展，在药物研发、临床试验及全球市场拓展方面对美国生物科技企业构成日益激烈的竞争。凭借政府强力支持、资本优势及创新疗法管线的持续扩充，在风险投资（VC）加持下的中国生物科技企业正在重塑行业格局。本环节将深入分析竞争态势、美国企业面临的挑战以及全球生物科技创新的未来走向。

  • 中国生物科技产业崛起："中国制造2025"战略对生物科技创新的推动效应
  • 监管加速作用：中国国家药品监督管理局（NMPA）在新药审批中的角色演进
  • 资本驱动力量：中美国际资本运作模式差异——中国风险投资与政府基金如何赋能生物科技初创企业
  • 美国企业的竞争压力：核心技术与市场份额的双重挑战
  • 监管与地缘政治因素：中美贸易摩擦及出口管制对生物科技合作的影响

OCT Advisory Board

Select a member to learn more

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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THOMAS M TREMBLAY
Vice President Of Clinical Development, Trefoil Therapeutics, Inc

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Bao Dinh
Global Development Business Operation, Takeda

With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
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