Outsourcing in Clinical Trials China 2026 2026中国临床试验外包大会

Outsourcing in Clinical Trials China is returning for a second year! This is your opportunity to engage at the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research.
中国临床试验外包大会第二年再度来袭！这是您投身临床研究增长最快的市场之一、站在临床试验创新前沿的绝佳机会。

8 - 9

September

2026
  • Renaissance Suzhou Hotel
  • Ticketed
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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Company Information

ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

To learn more, please visit our website - http://www.arensia-em.com/

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Nucleus Network is Australia’s largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. 

Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Combined, our clinics offer over 200 beds. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. 

Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. 

We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. 

Together with our client partners, we are fulfilling our purpose of ‘Advancing medicine, improving lives.’

Company Website

To learn more, please visit our website - https://www.nucleusnetwork.com/au/

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Akesa is an end-to-end provider of clinical trial supplies and services. Headquartered in Melbourne, Australia, Akesa boasts global reach with deep expertise in the Asia-Pacific region. We work alongside sponsors, CROs, research institutions, clinical trial sites and CDMOs to project manage the sourcing of finished products, including comparators, combination therapies, and standard-of-care medications, from validated suppliers and directly from manufacturers.

Company Website

To learn more, please visit our website - http://akesapharma.com/

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We’re more than a supplier: we’re a partner that can deliver consistent quality and superior service, a partner that fuels innovation to foster real and sustainable results. A deep understanding of the healthcare industry, our customers’ needs, and patient needs is critical to ensure our range of packaging products and services deliver value through the entire product lifecycle. These insights and the experience of the Smurfit Westrock Adherence & Clinicals team enable us to work in tune with regulations and clients to provide a service solution underpinned by an innovative and unparalleled range of packaging solutions that, at their heart, are patient focused. These include Clinical Trial Packaging, specialty labels, literature & booklets, Adherence packaging, component kits and SMART Digital Adherence Technology along with Digital Display Labels. Talk to us.

www.smurfitwestrock.com

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We are a global operational consulting firm helping Life Science companies stay compliant and inspection-ready. We specialize in Data Privacy (GDPR and global regulations), GxP Quality, and Computer System Validation. With senior-level experts across the EU, UK, and beyond, we support over 90 clients worldwide through audits, legal representation, and compliance excellence.

Company Website

To learn more, please visit our website - www.pharmarketing.net

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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

To learn more, please visit our website - www.novotech-cro.com

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Innovative Trials is a leading global clinical trial patient recruitment company. With over 10 years’ experience, Innovative Trials deploys “boots-on-the-ground” patient recruitment experts in over 70 countries, addressing individual sites’ unique patient recruitment and retention challenges in local language. Innovative Trials has experience in 25 therapeutic areas and 90+ conditions.

Company Website

To learn more, please visit our website - https://innovativetrials.com/

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Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

Company Website

To learn more, please visit our website - www.euromed-pharma.com

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    Why attend?

    Why attend? 为何参会？

    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

    • 8 Sep 2026
    • 9 Sep 2026
    Expand All

    8 AM

    Registration and refreshments 注册签到 & 茶歇交流

    8:50 AM

    Chairperson’s opening remarks 主席开幕致辞

    9 AM

    OPENING KEYNOTE: China’s Biopharma Leap: From Fast-Follower to Global Innovator 开幕主旨演讲：中国生物医药的跨越——从快速跟跑到全球创新

    China stands at an inflection point in global biopharma innovation. Having mastered the art of rapid development and commercialization as a fast-follower, the industry is now making a decisive strategic pivot towards becoming a true global innovator. The rise of China-led international multi-center trials (MRCTs) and landmark global partnerships underscores a new reality: China is no longer just a vast market or a development executor, but a primary source of scientific insight and therapeutic value.

    • From “Fast Follower” to Autonomous Innovation
    • Leveraging China’s Capabilities for Worldwide Development
    • From Local Assurance to Global Collaboration
    • Aligning Standards and Achieving Mutual Recognition
    • Building an Open, Collaborative Global Network

    中国正处于全球生物医药创新的关键转折点。作为快速跟跑者，中国已熟练掌握快速研发与商业化的核心能力，如今正坚定地向真正的全球创新者战略转型。中国主导的国际多中心临床试验的崛起，以及里程碑式的全球合作伙伴关系，揭示了一个全新的现实：中国不再仅仅是一个广阔的市场或研发执行方，而正在成为科学洞见与治疗价值的重要源头。

    • 从“快速跟跑”到自主创新
    • 借力中国能力赋能全球研发
    • 从本土保障到全球协作
    • 标准互认与监管对齐
    • 构建开放协作的全球创新网络

    9:30 AM

    Reserved for Sponsor 供应商专场

    10 AM

    KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主旨圆桌：患者入组革命——中国临床试验效率的全球启示

    Patient enrollment remains one of the most critical bottlenecks in global drug development, often delaying timelines, increasing costs, and limiting patient access to innovative therapies. Against this backdrop, China has emerged not merely as a region of vast patient numbers, but as a laboratory for systemic innovation in clinical trial execution.

    • How China Building Beyond "Population Advantage"
    • How to Leverage AI and Digital Platforms in Patient Matching
    • The Power of Hospital Alliances and Regional Clinical Hubs
    • What are the most effective patient-centric strategies to ensure trial success?
    •  How to Adapt China’s Model for International Multi-Center Trials
    患者入组仍然是全球药物研发中最关键的瓶颈之一，常常导致周期延误、成本攀升，并限制患者对创新疗法的可及性。在这一背景下，中国不仅凭借庞大的患者基数脱颖而出，更成为临床试验执行层面系统性创新的试验田。

    • 中国如何超越“人口红利”构建系统性优势
    • 如何利用人工智能与数字平台实现患者精准匹配
    • 医院联盟与区域临床中心的核心驱动力
    • 确保试验成功的患者中心策略有哪些有效实践
    • 如何将中国模式适配应用于国际多中心试验

    10:30 AM

    Morning refreshments and networking 上午茶歇及交流

    (Visit 3 booth at least)

    （请访问至少3个展台）

    11 AM

    The Next-Generation DCT Blueprint: AI-powered Network and Protocol-built Agility 下一代DCT蓝图：AI驱动网络与内嵌灵活性的方案设计

    • The “DCT-as-a-Service” Operating Model
    • The Modular Designed Protocols with “Build-in Agility”
    • The Rise of the Virtual Research Coordinator (VRC)
    • AI-Powered Feasibility & Predictive Patient Mapping

     

    • “DCT即服务”运营模式
    • 模块化方案设计与“内嵌灵活性”的方案起草
    • 虚拟研究协调员的崛起
    • AI驱动的可行性评估与预测性患者画像

    11:30 AM

    Reserved for Sponsor 供应商专场

    12 PM

    Intelligent Trial Design: Leveraging Real-World Evidence to Optimize Clinical Trials in China 中国创新药企全球化中心战略选址

    • Predicting Enrollment with Real-World Patient Journeys Balancing Scientific Rigor with Generalizability
    • Endpoint Optimization & Comparator Justification: Building a Persuasive Rationale
    • How to Support Hybrid, Pragmatic, and External Control Arm Trials
    • Access to Protocol Integration

     

    • 借力监管“桥头堡”：澳大利亚加速模式
    • 亚太临床网络的规模化与提速协同
    • 中国与全球同步开发的策略艺术
    • 技术赋能，打造新生态

    12:30 PM

    Reserved for Sponsor 供应商专场

    1 PM

    Lunch and networking 午餐及交流

    2:30 PM

    NMPA SPOTLIGHT The 2-3 x Speed Advantage: Inside China’s Integrated Discovery-to-IND Machine 2-3倍速优势：解码中国一体化发现至IND申报加速引擎

    • Strategic Meaning of NMPA 30-days Pathway
    • How to Leverage Platform & Technology Stack
    • Empowered by Capital & Talent Alignment
    • Lessons for Accelerating Worldwide Pipelines

     

    • NMPA 30天临床默示许可的战略内涵
    • 如何最大化平台与技术栈的杠杆效应
    • 资本与人才的同频共振
    • 全球管线的中国加速启示

    3 PM

    Reserved for Sponsor 供应商专场

    3:30 PM

    How a Scaled Local Ecosystem Fuels Global Innovation 本土规模化生态如何赋能全球创新

    China’s CRO/CDMO ecosystem has evolved from a basic service provider into a strategic, technologically advanced partner, offering unparalleled speed and integrated expertise. This ecosystem now serves as a fundamental and competitive pillar of the global biopharma supply chain, accelerating development and de-risking innovation for both domestic and international partners.

    • The Evolution from Cost Center to Strategic Innovation Partner
    • The Power of a Unified Service Chain
    • Specialization in New Modalities: Leading in ADC, CGT, and Beyond
    • How to Meet Global Standards
    • From Local Enabler to International Competitor

    中国的CRO/CDMO生态已从基础服务商，跃升为具备战略价值的技术驱动型伙伴，以前所未有的速度与一体化专业能力，成为全球生物医药供应链中不可或缺的竞争基石，为国内外合作伙伴加速研发、降低创新风险。

    • 从成本中心到战略创新伙伴的进化之路
    • 一体化服务链的协同势能
    • 新疗法领域的专精：ADC、CGT 的领跑优势
    • 如何与国际标准全面接轨
    • 从本土赋能者到全球竞技者

    4 PM

    Afternoon refreshments and networking 下午茶歇及交流

    4:30 PM

    CASE STUDY Clinical Trial at Warp Speed: How China Achieves 2-5x Faster Patient Enrollment 超速临床试验：中国如何实现2-5倍的患者入组效率

    • The "Mega-Site" Efficiency of Large Public Hospital Networks
    • Revolutionizing Patient Matching with National Databases & AI
    • Innovative Recruitment & End-to-End Engagement Strategies
    • The Standardized CRC Model and PI Collaboration
    • Translating the China Model for International Multi-Center Trials

     

    • 大型公立医院网络的“超级中心”效能
    • 国家数据库与人工智能驱动下的患者匹配革命
    • 创新招募策略与端到端患者 engagement 机制
    • 标准化CRC模式与研究者协同协作
    • 中国模式的国际化多中心试验移植路径

    5 PM

    PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论：领跑变革浪潮——重塑临床试验的核心趋势

    Clinical development is being reshaped by technology, new regulations, and a patient=centric focus. This panel will analyse key trends, from virtual trials to AI, separating hype from reality and providing a practical roadmap for leading the next generation of clinical research.

    • Practical Implementation of DCTs & Hybrid Models
    • Integrating RWE, AI, and Advanced Analytics
    • Evolving from Recruitment to True Engagement
    • Adapting SOPs, Vendor Partnerships, and Risk Management
    • Regional Variations in Adopting Next-Generation Trials

    技术革新、监管变革与患者中心理念正深度重塑临床研发格局。本场圆桌将紧扣从虚拟试验到人工智能等关键趋势，去伪存真，为领跑下一代临床研究提供可落地的行动路线图。

    • DCT与混合模式如何从试点走向实操
    • 真实世界证据、人工智能与高级分析技术的深度融合
    • 从“招募患者”进阶为“真正卷入”患者
    • 标准操作规程、供应商合作与风险管理如何顺势而变
    • 下一代试验落地：不可忽视的区域差异

    5:30 PM

    Chairperson’s closing remarks and Drinks Reception Sponsored 主席闭会致辞

    8 AM

    Registration and refreshments 注册签到与晨间茶歇

    8:50 AM

    Chairperson’s opening remarks 主席开幕致辞

    9 AM

    AI in Clinical Development: From Pilot to Production 人工智能在临床开发中的应用：从试点到投产

    • How to Build up Production-grade Systems from POC
    • Where is the Data and how is the Data
    • How to Prioritize the User Case
    • The Regulatory & Ethical Roadmap
    • 如何从概念验证跨越到生产级系统
    • 数据在哪里，质量又如何
    • 如何甄别用例的优先等级
    • 监管与伦理路线图

    9 AM

    AI in Clinical Development: From Pilot to Production 人工智能在临床开发中的应用：从试点到投产

    • How to Build up Production-grade Systems from POC
    • Where is the Data and how is the Data
    • How to Prioritize the User Case
    • The Regulatory & Ethical Roadmap
    • 如何从概念验证跨越到生产级系统
    • 数据在哪里，质量又如何
    • 如何甄别用例的优先等级
    • 监管与伦理路线图

     

    9:30 AM

    Reserved for Sponsor 供应商专场

    10 AM

    Beyond Oncology: Showcasing China’s Global-Ready Pipelines in Immunology & Metabolic Diseases 不止于肿瘤：中国免疫与代谢领域的全球级管线正在崛起

    • The Antibody Platform Advantage: Engineered for Immunology
    • Metabolic Disease Breakthroughs: From Fast Follower to Innovator
    • Global Validation Through Partnership & Capital
    • Pipeline Maturity: From Early Promise to Late-Stage Reality
    • The Strategic Infrastructure for Globalization
    • 抗体平台的优势迁移：为免疫学科身定制
    • 代谢疾病的创新突围：从快速跟跑到全球首发
    • 资本与合作的双重背书：全球化价值验证
    • 成熟管线路径：从早期概念到后期现实
    • 支撑全球化的战略基础设施

    10:30 AM

    Morning refreshments and networking 上午茶歇及交流

    （请访问至少3个展台）

    11:15 AM

    Strategic Site Selection for Globalizing Chinese Innovators 智能试验设计：借力真实世界证据优化中国临床试验

    • Leveraging Regulatory Bridgeheads: The Australia Acceleration Model
    • Orchestrating Asia-Pacific Networks for Scale and Speed
    • The Art of China-Global Synchronization
    • Integrating Technology to Create New Ecosystems
    • 基于真实世界患者旅程预测入组节奏
    • 科学严谨性与外部推演性的天平如何平衡
    • 终点优化与对照药选择依据：构建一个有说服力的逻辑闭环
    • 如何为混合型、实效型及外部对照臂试验提供支持
    • 真实世界数据如何接入方案整合流程

    11:45 AM

    PANEL DISCUSSION: Overview of Clinical Trial in Sites Application Overseas 圆桌讨论：海外临床试验中心申请全景洞察

    • How to Select the Strategic Country & Site
    • Decoding the Global Regulatory Map: Centralized Systems vs. National Labyrinths
    • Separating Marketing from Reality
    • Mastering the Institutional Labyrinth: From PI to Signed Contract
    • Building a Future-Proof Strategy: Alignment with ICH E6(R3) and Global INDs
    • 如何选定战略性国家与研究中心
    • 解码全球监管版图：集中审评体系 各国准入体系
    • 祛魅营销话术，直面落地现实
    • 攻克机构壁垒：从主要研究者到合同签署
    • 构建未来可延展的战略：对齐 ICH E6(R3) 与全球临床试验申请申报要求

    12:30 PM

    Lunch and networking 午餐及交流

    2 PM

    PANEL DISCUSSION Vision for the Future: The Future Roadmap of China’s Pharmaceutical Innovation 圆桌讨论：远见·未来：中国医药创新的征程与路线图

    China’s pharmaceutical innovation stands at a pivotal inflection point. After a decade of explosive growth, the industry is navigating a period of “capital winter,” intense policy-driven competition, and a strategic shift from the pursuit of quantity to the mandate of quality. However, this pressure is also a catalyst, forcing a clear-eyed re-evaluation of the path forward. Today, China is not just a vast clinical trial hub or a manufacturing powerhouse; it is defining its ambition to become a “world new drug creation center” by 2035.

    • The “Innovation Pivot”: From Fast-Follower to First-in-Class
    • The “Globalization 2.0” Playbook: From BD Transactions to Enduring Value
    • The “Dual Engine” of Policy: Regulatory Acceleration Meets Payment Reformation
    • Convergence and Concentration: Surviving the “Great Integration”
    • The Ultimate Alignment: Bridging the Pipeline to Unmet Clinical Need

    中国医药创新正站在一个关键的历史转折点。经历十年高速发展之后，行业步入“资本寒冬”，政策驱动的同质化竞争日趋激烈，发展逻辑正从追求数量向锚定质量深刻转型。然而，压力亦是催化剂，正倒逼全行业以更清醒的姿态重新审视前路。今天，中国不再仅仅是全球临床试验的聚集地或制药生产基地，它正在以2035年建成“世界级新药创制中心”为愿景，重新定义自己的全球坐标。

    • 创新力的转向：从快速跟跑到全球首创
    • 全球化0剧本：从授权交易到持久价值
    • 政策双引擎：监管提速与支付改革的同频共振
    • 收敛与集中：如何在“大整合期”存活并胜出
    • 终极对齐：让管线与未满足的临床需求精准接驳

    2:45 PM

    Speaker Hosted Roundtables 专家主持圆桌讨论

    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: How do we measure and incentivize long-term patient engagement and retention beyond the duration of a single trial?

    ROUNDTABLE 2: How do we transition from a cost-center logistics function to a value-creating strategic asset?

    ROUNDTABLE 3: What will it take for a Chinese company to be perceived as a peer and leader by the global biopharma ecosystem?

    互动式圆桌讨论为您提供一个与同行深度交流的独特机会，共同分享最佳实践，探讨行业面临的共性挑战并寻求解决方案。每场圆桌由行业专家主持，聚焦单一议题，以高互动性的形式助您拓展人脉网络，汲取同侪的经验与洞见。

    每场圆桌讨论时长为30分钟，设有轮换环节。

    圆桌讨论1

    单次试验结束后，我们如何衡量并激励患者的长期参与和保留？

    圆桌讨论2

    物流职能如何从“成本中心”转型为“价值创造型战略资产”？

    圆桌讨论3

    中国公司如何被全球生物医药生态视为平起平坐的同行乃至领导者？

     

    4 PM

    Lucky Draw & Chairperson’s closing remarks 幸运抽奖及主席闭幕致辞

    END OF CONFERENCE 会议结束

    OCT Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

    Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, CISCRP

    Behtash Bahador is the Senior Director of Community Engagement & Partnerships 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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    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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    Aditya Kotta
    VP Business Development, Novotech

    Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Opella

    Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

    I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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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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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
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