Archives: Agenda

• 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

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.

Moderator:

Fiona Barry, Editor in Chief & Director of Outsourcing, Globaldata Healthcare

Panelists:

Summer Xia, CEO & Founder, Trial-Data Medicine Li Zeng, CEO, Jing Medicine

Fiona Xing, Senior Director of Global Clinical Trial Supply, Brii Biosciences

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

• 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潜在影响

主持嘉宾:

Fiona Barry, 医疗健康部主席，GlobalData

论坛嘉宾:

夏素琴，创始人，创达医药曾雳，创始人，和径医药

邢新苗, 供应链高级总监，腾盛博药

• Working with Chinese CROs and CMOs – what global sponsors should
• Common difficulties for China sponsors going
• Managing cross-border clinical trials: logistics, communication, and cultural
• Case studies of successful global-China

• 与中国 CRO/CMO 合作——全球申办方必备指南
• 中国出海常见难点
• 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

• Case Studies on the Overseas Expansion of Chinese Medical Devices.
• Exploring the Global Medical Device Market: Where to Set Sail First?
• Practical Insights and Considerations for Multinational Clinical Trials.

• 中国医疗器械出海案例分享
• 全球医疗器械市场探索：出海第一站在哪？
• 跨国临床试验实战与注意点

• The impact of China’s biotech boom on global trials
• How do the global policies and regulatory difference impact the decision of China biotech
• The opportunities and challenges for clinical trials overseas and license out.

Moderator:

Xiaoyu Deng, Founder & CEO, MDCE

• 中国生物科技热潮对全球试验的影响
• 全球出海政策及监管差异对中国企业选择的决定影响
• License-out 与海外临床试验的不同机遇与挑战

主持嘉宾:

邓晓宇，创始人，希毅医学

• 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

• How AI tools are revolutionising rare disease patient enrolment and subsequently trial success?
• Can we make rare disease trials, protocols and study design simpler with limited data and patient populations?
• Training sites and staff on new systems to maximise the benefits of the latest technology and streamline processes
• Assessing the efficiency and success of pragmatic trials for more patient-centred approaches: do they work for rare diseases?
• Leveraging digital platforms and social media outreach to identify and recruit patients

Seats available