Bin Ni

Graduated from Tongji University, he currently serves as the General Manager of the Pharmaceutical Business Unit at The Fourth Construction Co., Ltd. of China Electronics System Engineering and as a Director of Kunshan Xieduoli Clean System Co., Ltd..
With nearly 20 years of extensive experience in project implementation management in the pharmaceutical engineering field, responsible for numerous key biopharmaceutical project constructions and implementations for companies such as AstraZeneca, Mindray, Hutchmed, and Thermo Fisher Scientific, focusing on providing full-process engineering services.

David SUN

深圳海普瑞药业集团制剂技术平台负责人
Shenzhen Hepalink Pharmaceutical Group's Head of Pharmaceutical Dosage Forms Technology Platform
《药品GMP指南》第2版无菌制剂分册撰稿人
Contributor to the "Pharmaceutical GMP Guide" 2nd Edition, Sterile Preparations Volume
《药品包装材料》编委
Editorial Board of 'Pharmaceutical Packaging Materials
国家局高研院、广东省局、IPEM等机构课程讲师
National Bureau High-level Research Institute, Guangdong Provincial Bureau and IPEM course instructor.
科创委重点项目在库专家、高新技术产业协会智库专家
Key Project Expert in the Science and Technology Innovation Commission's Database, Think Tank Expert of the High-tech Industry Association.
近20年制药工艺及质量管理经验，亲历近20次FDA/EMA审计
Nearly 20 years of experience in pharmaceutical process and quality management, with nearly 20 FDA/EMA audits experienced firsthand.
曾负责集团4个ANDA，23个SKU的美国市场开发项目及CMO合作
Responsible for the development of 4 ANDAs and 23 SKUs for the US market within the group, as well as collaborations with CMOs.
擅长工艺开发、技术转移、制剂生产到海内外注册上市的全周期管理流程
Skilled in the full cycle management process from process development, technology transfer, dosage form production to domestic and international registration and market launch.

Alex WANG

Dr. Wang has been in the pharmaceutical industry for more than 30 years, covering areas from drug research and development to quality management and operation. Familiar with lab management, setting up quality system and day to day quality operation, especially corporate quality management of Group Company. Led and passed GMP inspections by FDA，EU， Japan, WHO, and many other countries, for drug substances and drug products, including API ( sterile APIs), oral products, injection, and veterinary medicine. Familiar with domestic and foreign regulations, and has plenty of practical implementation experience. Dr. Wang also was the editorial board member of Guideline of Chinese GMP (2010).
Dr. Wang worked for several large companies (including MNCs) as quality head, he is now responsible for whole operation.as a VP in Nhwa Pharmaceutical Co.,Ltd

June WANG

Upon receiving Master in Fudan University, have engaged in Life Sciences with more than 20 years of experience about compliance and GMP. Experienced in the Life Science industry with providing the detailed GMP and digital solutions and complete execution solutions based on the GAMP guidance and regulatory requirements. Experienced lots of digital projects in Life Sciences included SCADA system, PCS system, WMS system, LIMS system, ERP system, BMS/EMS system, DMS system, QMS system, XHQ system, and etc.
Compliance and GMP Instructor for China International Pharmaceutical Machinery Exhibition, Digital Instructor for the Inspection Center of NMPA, Digital and Compliance Instructor for Research Programs in China Academy
GAMP® 5 (2nd Edition) Chinese Translation Project Manager, Certified Instructor for GAMP courses, DI courses and ANNEX 11/Part 11, Technical Support and Development of ISPE HQ GAMP Training Materials and Resources. Technical support and participate in GAMP South Asia technical and regulatory updating discussions. Attend ISPE Singapore 25th Anniversary Annual Meeting and promote digitalization and AI communication in Asia Pacific Region
Siemens Internal and External Compliance, GMP and GAMP Responsible.

Raymond ZHANG

Joined Novo Nordisk in 2006, holds Master Degree of Software Engineering and MBA.
20+ years working experience in Manufacturing IT, OT and Automation field of international pharmaceuticals corporation, especially in IT/OT technologies, Computer System Validation, Manufacturing Execution System, IT Compliance & Security and Smart Manufacturing. Rich experience in Manufacturing IT/OT project management and commercial-scale manufacturing IT/OT operation.15+ years working experience in project management and leadership of Manufacturing IT/OT and Automation field in international pharmaceutical corporation. Be familiar with PMP, GAMP, Agile Software Development project management and DevOps in GMP environment.
Rich project management experience in software development/test/validation/release, system integration and IT/OT system implementation in GMP environment. With rich experience on oversea co-operation, successfully accomplished a few international IT/OT projects, including various successful new production line introduction projects, pharma facility projects, automatic warehouse project and Industry 4.0 projects.
As expert in quality compliance management for computer systems in pharmaceutical enterprise. Especially deep understanding and using GxP regulation, 21 CFR Part 11, GAMP5, CSV, COBIT and IT Security to ensure compliance requirements for pharmaceutical enterprise.
As expert of pharmaceuticals manufacturing area to drive digital innovation and Smart Manufacturing/Industry 4.0 initiatives. As Pharma MES member and speaker, MESA International member and Yeehongedu Professor.

Ester Lovsin Barle

Ester Lovsin Barle is a global leader in product sustainability and stewardship, with over 28 years of work experience, including 16 years in the pharmaceutical industry. She holds a DVM, MSc, PhD, and MScTox degrees, and has extensive expertise in toxicology, occupational health, and environmental sustainability. She has led corporate, global Product Sustainability, Stewardship, Health and Hazard assessment functions at Takeda, Novartis, Sandoz and Lonza. Ester is the chair of ISPE Sustainability CoP.

Richard Chai

As a Senior Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical support and training to customers related to contamination control for cleanrooms, process equipment cleaning process and sterility assurance & maintenance. He is also a frequent industry speaker at industry events such as ISPE and PDA, and he is also a qualified ISPE trainer for ‘Cleaning Validation Principles Training Course’. Richard has more than 25 years of pharmaceutical industry experience in manufacturing, validation, consultancy and technical support.

SAMARA MATEIRO

Samara Mateiro has around 19 years experience in Pharma industry in quality systems. With a degree in Chemical Engineering from Faculdades Oswaldo Cruz (São Paulo, Brazil) and expertise in Qualification & Validation (Q&V), regulatory frameworks, and auditing and inspections and quality governance.
In her current global role at Sanofi, she holds the position of Quality Intelligence & Advocacy lead, advocating for responsible Artificial Intelligence use in Pharma into quality decision-making, quality systems, among other topics. Her work focuses on enabling proactive, risk-based, and predictive quality strategies, while shaping the future of quality systems through innovation and global collaboration. She is honored to be a keynote speaker at the ISPE China Conference, contributing to discussions on the next generation of pharmaceutical quality.

Xiaobo TANG

In 2009, he pursued postgraduate studies in Medicinal Chemistry at China Pharmaceutical University, focusing on the research of novel anti-tumor drug resistance agents, and published multiple SCI papers.

In 2012, he engaged in new drug research at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. His research focused on protein structure-based drug molecular design, synthesis, and pharmacological activity evaluation.

From 2013 to the present, he has long been engaged in the supervision and inspection of drug production, circulation and utilization within the Shanghai municipal drug regulatory system. He currently works in the Drug Supervision Division of Shanghai Municipal Medical Products Administration, primarily responsible for the regulation of biological products such as vaccines, blood products and CGT products, as well as chemical active pharmaceutical ingredients (APIs) in Shanghai.

He led the formulation of the regulatory document *Administrative Measures for Key Quality and Safety Management Personnel of Pharmaceutical Production and Operation Enterprises in Shanghai*, revised the *Shanghai Municipal Supervision and Administration Provisions on Autologous Chimeric Antigen Receptor T-Cell (CAR-T) Products*, and promoted the implementation of the local standard *Specifications for the Construction and Operation of the Full-process Digital Traceability System for Drug Production*. He also participated in the formulation of supporting association standards and specifically handled the pilot work of segmented production for biological products in Shanghai.

Jianjin YU

Yu Jianjin graduated from Shanghai University of Technology in 1987 and holds professional qualifications as a Certified Safety Engineer, Environmental Protection Engineer and Senior Security Specialist. He is currently engaged as a consultant of Shanghai Energy Conservation and Environmental Protection Service Association and Shanghai Biomedical Frontier Industry Innovation Center. Meanwhile, he is one of the first specially-appointed experts of the EHS Management Professional Committee of China Pharmaceutical Enterprise Management Association, as well as an examiner for Level 1, Level 2 and Level 3 Security Administrators in Shanghai.

Throughout his career, he has worked for renowned enterprises including Roche, DSM and Somage, specializing in overall EHS system management for a long time. He joined Shanghai Pharmaceutical (Group) Co., Ltd. in 2009 and served successively in the Group’s Technology & Quality Department and Security Department. He took charge of the overall management of work safety, ecological environmental protection, energy control, public security and protection across the Group. He has participated in the compilation of Shanghai Pharmaceutical’s ESG and Social Responsibility Reports for sixteen consecutive years.

Manyang LIN

Mr. Lin Manyang, Senior Engineer, Senior Principal Engineering of Innovent Biologics. He has more than 20 years of experience in the life cycle management of international standard biopharmaceutical projects. He has rich experience in GMP operation of biopharmaceutical facility , and has rich experience in accepting GMP certification and international customer audits. Familiarity with international pharmaceutical standards, norms and guidelines; Familiar with the trend and latest practices of international biopharmaceutical project .He has published more than 10 professional papers , and shared his experience in biopharmaceutical project management and operation as an expert in conferences and forums such as ISPE, Pharmengin, Vogel, E-Trade, and PIIF.

Lu WANG

Sydney WANG

Wang Xiahuanzi is the Head of the Digital and Intelligent Engineering Division at Pharmengin, a Senior Automation Engineer, a Smart Manufacturing Engineer, and a PMP-certified Project Manager. With 17 years of experience in the design and management of digital and intelligent projects in the pharmaceutical and fine chemicals sectors, she has led over 100 automation and information system construction projects as the technical lead. Her clients include renowned domestic and international pharmaceutical companies such as Pfizer, Hengrui, Fresenius Kabi, Innovent,CR BOYA-BIO, and SHANGHAI RAAS. She has been deeply involved in the development of Sinopharm Group’s smart factory tiered cultivation and evaluation system, possessing end-to-end practical experience spanning project design, implementation, and the establishment of industry standards.

Sharp DING

Sharp Ding, Expert in Pharmaceutical Digital Strategy, with over 30 years of experience in enterprise informatization and digitalization projects, and 25 years of practical experience in end-to-end digitalization across the entire pharmaceutical industry chain. Led the formulation and implementation of the 12th Five-Year Plan, 13th Five-Year Plan and 14th Five-Year Plan digital strategies for large-scale pharmaceutical groups. Deeply involved in and successfully delivered more than 30 large-scale pharmaceutical digital projects covering pharmaceutical R&D, intelligent factory design, pharmaceutical production management, quality management (GxP), operation management (ERP), circulation traceability and supervision, etc. In the field of pharmaceutical intelligent manufacturing, participated in or led the top-level design of intelligent manufacturing strategies for three listed pharmaceutical companies. Meanwhile, actively explored the integrated innovation of artificial intelligence and pharmaceutical businesses, as well as the application paths of artificial intelligence in drug R&D and pharmaceutical process optimization.

William GUO

William GUO holds a Master’s degree in Pharmacology from Zhengzhou University. With over 10 years of experience in leading global pharmaceutical and medical device companies, he co-founded Shanghai InnoPac Medical Technology Co., Ltd. and currently serves as Vice President of R&D, overseeing the company’s entire product pipeline development. He has spearheaded the establishment of four core product platforms: Drug Injection Systems, Aseptic Drug Transfer Systems, Self-Injection Systems, and Home Aesthetics. Under his leadership, the company has launched a series of innovative products with independent intellectual property rights, holding over 60 authorized patents, including 12 invention patents.

Stephan Rennecke

Dr. Stephan Rennecke holds a PhD in Solids Process Engineering from Clausthal University of Technology. He has broad experience across the process industry, machine development, and manufacturing digitalization, including previous roles in the cosmetics industry.
Since 2024, he has been with Fette Compacting, where he leads the Future Technologies department. In this role, he is responsible for technology scouting and the strategic pre-development of new technologies for pharmaceutical manufacturing. His work focuses on identifying emerging technology trends and translating them into future-oriented solutions for oral solid dosage production.
Since 2026, Dr. Rennecke has also been heading the AI Hub at Fette Compacting. Together with his team, he develops new digital and AI-based solutions, with a focus on smart assistants, data-driven process support, and future concepts for autonomous manufacturing.
His current work combines process engineering, pharmaceutical production technology, and digital innovation to support the development of smarter, more flexible, and more efficient manufacturing solutions.

Sam SUN

From the irresistible trend of AI technology development, to the AI-driven transformation guided by domestic and foreign regulatory authorities, and even the need to break through industry involution, intelligent transformation has become a universal consensus—it is no longer a question of "if," but of "how" and "when." As a domestic macromolecular CDMO, Zencore Biologics has been dedicated to enhancing its core competitiveness through standardization, digitalization, and intelligence. In this presentation, we aim to share our practices and insights from the perspectives of regulations, management, and technology, drawing on practical cases such as MAH-CDMO collaboration, AI-assisted GMP review, and AI-aided auditing. We look forward to exchanging ideas and learning with peers and customers to accelerate and deepen the value transformation of intelligent initiatives in the pharmaceutical industry.

Yi CHEN

Ms. Yi Chen. Currently serving as a Principle Sterility Assurance Engineer in the Technical Services and Manufacturing Science Department at Eli Lilly Suzhou Pharmaceutical Co., Ltd. Responsible for developing and implementing environmental monitoring and aseptic process simulation and other sterility assurance strategies. With more than 10 years of experience in the pharmaceutical industry, she has extensive experience in environmental monitoring management, clean utility system validation, and sterility assurance. She has actively participated in provincial, national, and EU PAI/GMP audits, contributing to audit responses and decision-making. Ms. Chen is frequently invited as a speaker at PDI and CPEC conferences and Peking University’s IPEM sterility assurance courses. She holds a Master’s degree in Food Science from Purdue University, USA.

Bin WANG

Bin Wang is the Director of Customer Application team in Merck, wherein he leads a strong globally networked group including Technical Application Expert, Field Marketing, Segment Marketing, Marketing Communication and Product Manager. This group provides comprehensive product and application solution covering from upstream to downstream, development marketing strategies and events. Before this position, he used to lead China Technical and Scientific Team, Asia MSAT team, Great China Process Development team etc. Between 2016 to 2017, Bin Wang worked in EMD Millipore USA MSAT team. Bin Wang has 21 years’ experience in Biopharmaceutical industry in both Asia and USA. Before Merck, Bin Wang worked in FOSUN PHARMA, Asia United Mab Company and BMS as PD and GMP compliance management roles. He is the lecturer of Separation course at East China University of Science & Technology, used to be the lecturer of NMPA Institute of Executive Development, Peking University’s IPEM program.
He is also the Singapore WDA qualified trainer. He has served as the speaker, chairman and panel discussion moderator in several international academic conferences in China and North America, including conferences organized by ACS/IBC/BIT/DCVMN/VacChina/WVC/Affinity etc.

Rainer Nicolai

Dr. Rainer Nicolai is the product owner Engineering Consulting at Roche's headquarter site at Basel/Switzerland. He has worked as a project manager for more than 20 yearsand is a subject matter expert on containment technologies covering the whole manufacturing value chain.

Aaron ZHOU

Aaron Zhou graduated from Tongji University with a master's degree in HVAC and energy conservation. With over 17 years of experience in sustainable and low-carbon consulting, including energy efficiency optimization diagnosis, carbon emission reduction path planning, digital energy management planning, energy-saving management training, zero carbon factory and park consulting, etc for high energy consuming enterprises. I have rich experience in consulting on sustainable development (energy conservation and low-carbon) in both existing and newly built factories, especially in projects for pharmaceutical companies.
Aaron Zhou has a lot of experience in the pharmaceutical industry, especially in improving energy efficiency in pharmaceutical companies. His experience not only includes energy-saving of public auxiliary facilities, but also has accumulated much in process production

Jianchen XU

Dr. Xu Jianchen, currently serving as the Director of Quality Intelligence at Novo Nordisk, is responsible for providing advice and solutions on quality compliance in China, as well as providing technical support for inspection preparation and on-site operations.
I have held multiple quality management and expert positions at Novo Nordisk site Tianjin and European site. I have over ten years of rich practical experience in GMP, aseptic production environmental monitoring, quality assurance, quality system and other fields in the production of biological products. Familiar with the regulatory systems, industry positions, and practical trends in Europe and China.
Bachelor of Pharmaceutical Chemistry from China Pharmaceutical University, Ph.D. in Applied Chemistry from Tianjin University

Xiaobin CHEN

Chen Xiaobin currently serves as the Director of Validation at Zhejiang Hisun Pharmaceutical Co., Ltd. He holds a Bachelor's degree in Pharmaceutical Formulation from Shenyang Pharmaceutical University and a Master's degree in IPEM from Peking University. With over 20 years of experience in the pharmaceutical industry, he possesses extensive expertise in project management and regulatory auditing. His focus is on integrating risk management models and statistical methods into quality management to address practical challenges and achieve precise control of product quality risks. He contributed to the compilation of the 2023 edition of the "Drug GMP Guidelines: Active Pharmaceutical Ingredients."

Raymond ZHANG

Joined Novo Nordisk in 2006, holds Master Degree of Software Engineering and MBA.
20+ years working experience in Manufacturing IT, OT and Automation field of international pharmaceuticals corporation, especially in IT/OT technologies, Computer System Validation, Manufacturing Execution System, IT Compliance & Security and Smart Manufacturing. Rich experience in Manufacturing IT/OT project management and commercial-scale manufacturing IT/OT operation.15+ years working experience in project management and leadership of Manufacturing IT/OT and Automation field in international pharmaceutical corporation. Be familiar with PMP, GAMP, Agile Software Development project management and DevOps in GMP environment.
Rich project management experience in software development/test/validation/release, system integration and IT/OT system implementation in GMP environment. With rich experience on oversea co-operation, successfully accomplished a few international IT/OT projects, including various successful new production line introduction projects, pharma facility projects, automatic warehouse project and Industry 4.0 projects.
As expert in quality compliance management for computer systems in pharmaceutical enterprise. Especially deep understanding and using GxP regulation, 21 CFR Part 11, GAMP5, CSV, COBIT and IT Security to ensure compliance requirements for pharmaceutical enterprise.
As expert of pharmaceuticals manufacturing area to drive digital innovation and Smart Manufacturing/Industry 4.0 initiatives. As Pharma MES member and speaker, MESA International member and Yeehongedu Professor.

Dalong LI

Li Dalong is employed by Yangtze River Pharmaceutical Group, serving as the technical director of the group's limited factory. His responsibilities include product technology transfer, process validation, cleaning validation, equipment qualification, post-market product process improvement, and registration and filing. With 25 years of experience in the quality and technical management of chemical drug production, he is dedicated to the application of production technology and lean improvement. He has designed and established three independent freeze-dried powder injection production lines and has been in charge of their independent operation for over 10 years. He has also participated in the entire process of the factory's first EU project for injectables and the FDA project for freeze-dried powder injections.

Alex WANG

Dr. Wang has been in the pharmaceutical industry for more than 30 years, covering areas from drug research and development to quality management and operation. Familiar with lab management, setting up quality system and day to day quality operation, especially corporate quality management of Group Company. Led and passed GMP inspections by FDA，EU， Japan, WHO, and many other countries, for drug substances and drug products, including API ( sterile APIs), oral products, injection, and veterinary medicine. Familiar with domestic and foreign regulations, and has plenty of practical implementation experience. Dr. Wang also was the editorial board member of Guideline of Chinese GMP (2010).
Dr. Wang worked for several large companies (including MNCs) as quality head, he is now responsible for whole operation.as a VP in Nhwa Pharmaceutical Co.,Ltd

June WANG

Upon receiving Master in Fudan University, have engaged in Life Sciences with more than 20 years of experience about compliance and GMP. Experienced in the Life Science industry with providing the detailed GMP and digital solutions and complete execution solutions based on the GAMP guidance and regulatory requirements. Experienced lots of digital projects in Life Sciences included SCADA system, PCS system, WMS system, LIMS system, ERP system, BMS/EMS system, DMS system, QMS system, XHQ system, and etc.
Compliance and GMP Instructor for China International Pharmaceutical Machinery Exhibition, Digital Instructor for the Inspection Center of NMPA, Digital and Compliance Instructor for Research Programs in China Academy
GAMP® 5 (2nd Edition) Chinese Translation Project Manager, Certified Instructor for GAMP courses, DI courses and ANNEX 11/Part 11, Technical Support and Development of ISPE HQ GAMP Training Materials and Resources. Technical support and participate in GAMP South Asia technical and regulatory updating discussions. Attend ISPE Singapore 25th Anniversary Annual Meeting and promote digitalization and AI communication in Asia Pacific Region
Siemens Internal and External Compliance, GMP and GAMP Responsible.

David SUN

深圳海普瑞药业集团制剂技术平台负责人
Shenzhen Hepalink Pharmaceutical Group's Head of Pharmaceutical Dosage Forms Technology Platform
《药品GMP指南》第2版无菌制剂分册撰稿人
Contributor to the "Pharmaceutical GMP Guide" 2nd Edition, Sterile Preparations Volume
《药品包装材料》编委
Editorial Board of 'Pharmaceutical Packaging Materials
国家局高研院、广东省局、IPEM等机构课程讲师
National Bureau High-level Research Institute, Guangdong Provincial Bureau and IPEM course instructor.
科创委重点项目在库专家、高新技术产业协会智库专家
Key Project Expert in the Science and Technology Innovation Commission's Database, Think Tank Expert of the High-tech Industry Association.
近20年制药工艺及质量管理经验，亲历近20次FDA/EMA审计
Nearly 20 years of experience in pharmaceutical process and quality management, with nearly 20 FDA/EMA audits experienced firsthand.
曾负责集团4个ANDA，23个SKU的美国市场开发项目及CMO合作
Responsible for the development of 4 ANDAs and 23 SKUs for the US market within the group, as well as collaborations with CMOs.
擅长工艺开发、技术转移、制剂生产到海内外注册上市的全周期管理流程
Skilled in the full cycle management process from process development, technology transfer, dosage form production to domestic and international registration and market launch.

Daniel GAO

Yutao HUA

The Vice President of Shanghai BiBo Biopharma Engineering Co., Ltd., formerly served as Director of the Department of Chemical Drugs and Medical Devices and the Department of Biological Resources and Safety at the China National Center for Biotechnology Development. In 2019, he was appointed by the Organization Department of the Communist Party of China as Director of Planning, Development, and Informatization at the Health Commission of Hainan Province.
His experience includes contributing to the drafting of the "Key Special Projects for New Drug Innovation" implementation plans, developing the strategic roadmaps for biomedicine and medical devices for the Ministry of Science and Technology, assisting in formulating the "National Biotechnology Development Strategy Outline," and leading revisions to the "Implementation Rules for the Administration of Human Genetic Resources" and the "14th Five-Year Plan for Health and Wellness in Hainan." Skilled in strategic planning, policy development, and corporate management.
Yutao Hua graduated from Tsinghua University with a MS in Microbiology.

Huilin ZHU

Head of Clinical Manufacturing at WuXi Biologics, with 15 years of experience in the biopharmaceutical industry.
Supervising a clinical manufacture network with cell banking and drug substance GMP facilities operating at multiple sites, to deliver DS with global quality standards.
Deep expertise spanning cell culture process development, DS technology transfer & scale-up, pilot production , GMP manufacturing and quality management.
Multiple years of end to end CMC lifecycle management of biopharmaceutical products with modalities encompassing mAb, bsAb and ADC.
Core member of ISPE China Biologics Process and Production sub-committee since 2022. Led planning and execution of ISPE activities including ISPE China Annual Meetings, online and offline sub-committee activities.

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy.
Holding an M.Sc. in Biochemical Engineering from the University of Birmingham, Shanshan brings 18 years of global experience across consulting firms and pharmaceutical giants like Novartis, focusing on process, quality, compliance, and regulatory areas.
Shanshan is passionate about connecting people and technologies in the life science industry and is devoted to fostering international collaborations. She currently serves on the ISPE International Board, contributing to its global mission and vision.

庞飞飞 Sophie

康伟

0+ years of ISPE member Member of ISPE China Biological Committee Vice President, Austar, 2019-01 to Present Senior specialist and SME, NNE 2007- 2019
 With 28+ years of work experience in biopharmaceutical and pharmaceutical industry as project sponsor and project lead, Mr. Kang Wei takes role as Vice President in AUSTAR Group at present and focus on pharmaceutical engineering and project management. He works on strategy planning and biotech facility engineering as international biotech facility expert with visionary approach. Highlight clients & projects (GMP commercial production facility) as follows: Bill & Melinda Gates Foundation, NovoNordisk, GSK, Novozymes, Boehringer-Ingelheim, Adimmune, Henlius, Wuxi Biologics, Junshi, BeiGene, Carsgen, Gracell.
 Mr. Kang Wei coordinated with international team to provide professional consulting services for international and domestic clients in terms of Vaccine, Monoclonal Antibody, ATMP, ADC, etc., the project standards comply with FDA, EMA, WHO and NMPA.
 International organizations and forums：
 “Establishing Biotech Manufacturing Capacity in China” in 2015, IBC Life Sciences D development and Production (BDP) Week, in Huntington Beach, CA. 
 “Bio facility consideration from engineering perspective” in 2016, ISPE Biologics Development Symposium in Hangzhou
 “Best practice for Bio project execution “in 2017, ISPE Biologics Forum in Benxi 
 “Global Practice Bridge to Local Manufactures “in 2018, ISPE / CIPM in Chongqing
 “THE MANUFACTURING ROAD “Panel discussion in 2019, BioCentury & BayHelix China Summit in Shanghai
 “GMP trend and expectation for cell therapy facility” in 2019, ISPE "Innovative technology and concept for state-of-the-art biologic facility" session in Changsha
 “Case study - Compliant and Efficient biologic facility “in 2020, ISPE / CIPM in Chongqing

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技(上海)有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于寻找新的商业机会，以实现销售和服务的快速扩展。他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有深入的理解，是生产数字化转型领域的权威专家。在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自2019年3月起，他开始在柯尔柏医药科技中国区担任董事总经理。他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China University of Science and Technology, currently serves as the Managing Director of Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs of the Körber Business Area Pharma in China, committed to seeking new business opportunities to achieve rapid expansion of sales and services. He has more than twenty years of profound experience in the life sciences industry particularly in areas such as research and development, production, pilot production processes, production equipment, and automation hardware and software. He has an in-depth understanding of the entire process of the pharmaceutical and biotechnology industry, as well as is an authoritative expert in the field of digital transformation in production. During Jerry's career, he has held senior management positions in technology, sales, and business development in several industry-leading companies such as Harro Hofiger and Rockwell Automation. He has been recognized multiple times for his outstanding performance. Since March 2019, he has been serving as the Managing Director of Körber Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully formulated and implemented the company's strategic goals, leading the team to achieve breakthrough development, thereby further expanding the company's sales and market influence in China.

Matt Burns

Matt lives in Cambridge Massachusetts and leads Takeda’s R&D/Clinical Global Import/Export Operations and Trade Compliance activities.
He is a U.S. Licensed Customs Broker and global logistics and customs compliance expert with over 25 years of experience supporting global supply chains.
Matt specializes in global import/export operations, trade compliance, and customs strategy for manufacturing, regulated products, including clinical trial materials and commercial pharmaceuticals.

Jing DU

Chen GU

Gu Chen Graduated with a degree in engineering and computer engineering. Joined Syntegon (former Bosch Packaging Technology) in 2011. Experienced with kinds of aseptic filling finish process and now is dedicated on complex filling process solutions, technical transfer and market promotion.

Ke ZHANG

Mr. Zhang Ke is a Senior Industry Consultant for Life Sciences at Rockwell Automation, with over 20 years of expertise in industrial informatics and digital solutions. During his 15-year tenure at Rockwell, he has specialized in the design and implementation of MES for the pharmaceutical sector, with extensive knowledge of production processes in OSD, sterile preparations, and vaccines. Having been deeply involved in digital transformation projects for major domestic vaccine manufacturers, he excels at developing digital blueprints rooted in fundamental process requirements. Currently, Zhang Ke focuses on the integration of informatics, hybrid modeling, and automation to help pharmaceutical companies achieve process excellence and compliant manufacturing.

Yaping CHEN

Christian Wölbeling

Christian Wölbeling is a seasoned ISPE member with 25 years of experience. He currently serves as Chair of the ISPE Pharma 4.0™ Community of Practice and is actively involved in the GAMP® and Process Analytical Technology (PAT) Communities of Practice. A recognized expert in pharmaceutical digitalization, Christian has contributed to several ISPE guides, including the GAMP® Guide: Records and Data Integrity and the APQ Guide: Process Performance and Product Quality Monitoring System. He is currently leading a team to develop an ISPE guidance document on Pharma 4.0™.
With over 30 years at Körber, Christian now holds the position of Executive Industry Advisor and Senior Strategic Account Manager, based in Lüneburg, Germany. A pioneer in pharmaceutical digitalization, he joined Werum Software & Systems (now part of Körber) in 1992, where he led the development of production management software for top pharmaceutical companies such as Bayer, Novartis, and AstraZeneca. In 2015, he co-created the Pharma 4.0™ concept with Marcel Staudt, bridging Industry 4.0 automation with pharmaceutical ICH guidelines to drive digital transformation in the industry.
Christian believes that breaking silos between quality, operations, and engineering enables data-driven control strategies, accelerating therapeutic innovation and optimizing production processes for the benefit of patients. His work has had a profound impact on the digitalization and automation of the pharmaceutical industry.
Christian Wölbeling 是ISPE的资深成员，拥有25年的会龄。他现任ISPE Pharma 4.0™实践社区主席，并积极参与GAMP®和过程分析技术（PAT）实践社区的工作。Christian 在制药行业数字化领域具有丰富经验，曾参与编写多部ISPE指南，包括《GAMP®指南：记录与数据完整性》和《APQ指南：过程性能与产品质量监控系统》。目前，他正领导团队制定关于Pharma 4.0™的ISPE指导文件。
Christian 在柯尔柏工作超过30年，现任执行行业顾问和高级战略客户经理，常驻德国吕讷堡。作为制药行业数字化的先驱，他于1992年加入维隆软件与系统公司（现为柯尔柏集团的成员公司），主导开发了多项制药生产管理软件，客户包括拜耳、诺华、阿斯利康等全球顶级制药企业。2015年，他与Marcel Staudt共同提出Pharma 4.0™概念，旨在将工业4.0的自动化理念与制药行业特有的ICH指南相结合，推动制药行业的数字化转型。
Christian 坚信，通过打破质量、运营和工程之间的壁垒，制药企业可以实现数据驱动的整体控制策略，加速治疗创新并优化生产流程，最终造福患者。他的工作对制药行业的数字化和自动化发展产生了深远影响。

Daisy YUE

Daisy Yue, Master and MBA of HUST, currently serves as Director of Pharmaceutical Business Unit, Greater China at testo. With more than 15 years of experience in the pharmaceutical industry, she has worked in well-known industry enterprises such as Austar and Sinopharm Engineering, accumulating rich practical experience in the pharmaceutical and biological fields, and has been deeply engaged in the industry for many years to help enterprises achieve business expansion and compliant operation in the pharmaceutical field. With her excellent leadership and strong sense of responsibility, she has successfully formulated and implemented the strategic goals of the Pharmaceutical Business Unit, leading the team to achieve breakthrough development, thereby further expanding the company's sales scale and industry influence in the Greater China pharmaceutical market.

Gang LING

Shanti Marlina Sibuea

Shanti Marlina Sibuea is a seasoned professional with a strong educational background and over 15 years of experience as a GMP Inspector and WHO Temporary Advisor. She earned her PhD in stem cell biology from Monash University, Australia, and holds a Master’s degree in Biopharmaceutical Science from Leiden University, the Netherlands, along with Pharmacy and Apothecary degrees from the University of Indonesia. Throughout her career at the Indonesian FDA (Badan POM), she has led and participated in numerous high-level inspections of ATMPs, vaccines, biosimilars, and sterile pharmaceutical facilities. She is also an experienced speaker at national and international forums, including the PDA Conference, WHO meetings, and the PIC/S Expert Circle, and has served as a trainer in GMP forums and regulatory strengthening programs in countries such as India, China, Papua New Guinea, Thailand, the Philippines, and Malaysia. Her international engagement includes serving as a WHO consultant and expert trainer, supporting regulatory system strengthening, quality assurance, and biopharmaceutical product oversight across various countries.

Rosemary Hu

Rosemary Hu is the leader of Deloitte Nanjing tax team. She is also a tax partner in International Tax and M&A service line with 22 years of professional tax consulting experiences. She has a diverse background serving MNC, SOE, listed companies, and high potential local large enterprise groups in Jiangsu and Anhui province. She has significant experience across a range of industries. Rosemary was continuously nominated as Highly Regarded Practitioner and Women Leader in Tax by World Tax. She is also an executive director of Jiangsu CCTAA (“The China Tax Certified Tax Agents Association”). Ms. Hu holds a BA from the law School of Nanjing University and she is a member of Chinese Institute of Certified Public Accountants (CICPA) and Certified Tax Agent in PRC. Ms. Hu is the vice chair of Amcham Nanjing Center Advisory Council.

Hunter SONG

Expert in bio-medicine consulting and planning, Registered Electrical Engineer in the United States, Deputy Director of the Pharmaceutical Engineering Technology Expert Committee of the International Pharmaceutical Project Management Association (IPPM) China Region, Standing Committee Member of the Pharmaceutical Technology Professional Committee of China Pharmaceutical Education Association, Director of the Recombinant Drug Branch of China Biochemical Pharmaceutical Industry Association. Vice Chairman and Vice Chairman of the Science and Technology Committee of TIANS Group. Bachelor of Yanshan University (2010), Master of The University of Toledo (2013), Master of Peking University. He has worked in SSOE Group, CITIC Dicastal Co., Ltd., and AUSTAR Group. He focuses on the fields of antibodies, vaccines, biological preparations, solid preparations, and sterile preparations. He is proficient in industrial strategic planning and design, product pipeline layout and trend research and judgment, and has complete execution experience from process development and technology achievement transformation to conceptual design, engineering implementation, and commercial production transformation. He has led many large-scale projects such as BeiGene Guangzhou ADC&DS4 Workshop Project, BeiGene Shanghai Innovation Center Project, University Biomedical Technology Transfer and Transformation Center Project, Henkel Green High-end Adhesive Industrialization Base Project, Luye Pharma CNS Recombination and Drug R&D Production Base Project, and Guangzhou InnoCare Anti-cancer Drug Production Base Construction Project.

Ning MI

Mi Ning graduated from Nankai University with a master’s degree in Physical Chemistry. After graduation, she joined WuXi AppTec, BioDuro, and BeiGene, working in new drug development and Supply Chain. In December 2020, she joined Dizal Pharmaceutical as Clinical Supply Chain Lead. Drawing on over ten years of global supply chain experience and strong leadership, she built and led the supply team in alignment with the company’s development strategy, forecasted IMP production, managed clinical supply across global and domestic trials, and achieved the company’s development goals in a compliant and effective manner.

Menglong LI

Tony MAO

Tony Mao holds a Master’s degree from the University of Chinese Academy of Sciences and a Bachelor’s degree from Beijing University of Posts and Telecommunications. He currently serves as Head of the IT Department at Lepu Biopharma Co., Ltd., where he is driving digital transformation and AI-powered intelligence across key domains—including preclinical R&D, clinical trials, CMC, quality management, marketing and sales operations, supply chain management, and human resources management etc. His leadership has delivered compliant, efficient, and intelligent business outcomes.
Previously, Mao Lei served as IT Leader at China Potevio Corporation (a central SOE and former top-ranked enterprise in China’s Top 100 Electronics List) and BlueFocus Group (China’s largest digital marketing group), bringing extensive cross-industry and enterprise-group experience in digitalization, and large-scale IT governance.

Shannon WANG

25年以上IT、自动化实施经验 More than 25 years of experience in IT and automation implementation
20年以上计算机化系统验证经验 More than 20 years of experience in computerized system validation
参与2015中国计算机化系统附录的培训 Participated in the 2015 China Computerized System Appendix Training
ISPE中国本地GAMP, DI, C&Q及GMP基础培训师 Certified ISPE local GAMP, DI, C&Q, and GMP Foundation trainer
为受监管公司和供应商提供咨询，审计和培训 Consulting, auditing and training for regulated companies and suppliers
支持厂房设施设备的验证 Support the Qualification and Validation of facilities and equipment
曾就职辉瑞（美国），强生（中国），药明生物
Employed in Pfizer (USA), Johnson & Johnson (China), and WuXi Biologics

Yifei CHEN

Dr. Yi-Fei CHEN, the head of Innovation and Regulatory Science Development Department, Shanghai Center for Drug Evaluation and Inspection (SCDEI), China. She is responsible for researching platform construction for drug regulatory science in SCDEI.

Chong hock Sia

Mr. Sia Chong Hock has been the Director of Quality Assurance and Senior Consultant of Audit and Licensing at the Singapore Health Sciences Authority (HSA) since 2015, where he was previously the Director of the Audit and Licensing Division in the period 2008 to 2015. From 1995 to 2022, he was also an Adjunct Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS). He had been a member of the Singapore Pharmacy Council and its predecessor Singapore Pharmacy Board from 2002 to 2018, including being the Chair of its Complaints Panel. He holds a Bachelor’s degree in Pharmacy from NUS, as well as a Master’s degree in Healthcare Management (with Distinction) from the University of Wales, UK.
Mr. Sia has played a monumental role in, and won several awards for, shaping Singapore to be a world leader in pharmaceutical regulation. He took up the challenge to set up the GMP Audit Unit and led Singapore to become the first Asian member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2000, and was subsequently appointed Chair of the ASEAN MRA Task Force and Joint Sectoral Committee on GMP Inspection from 2005 to 2020. In 2013, he was conferred the Industry Pharmacist of the Year Award by the Pharmaceutical Society of Singapore, and in 2016, he was honored with the International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Affiliate Lifetime Achievement Award for his contributions to the field of Pharmaceutical Regulatory Practices in Singapore and the ASEAN region. More recently, he was a recipient of the PS (Health) Award 2023 for his key role as a core team member responsible for HSA being the first National Regulatory Authority (NRA) in the world to achieve Maturity Level 4 under the World Health Organization Global Benchmarking Tools (WHO GBT) assessment. This WHO GBT certification confirms HSA as an NRA that is operating at an advanced level of regulation in medicinal products and vaccines. On the academic front, he contributes review articles regularly to international scientific journals, covering the regulation of pharmaceuticals and biopharmaceuticals. In 2016 and 2019, two of his articles won the ISPE Roger Sherwood Article of the Year Award.

Xiaodan SUN

Ms. Sun Xiaodan has over 20 years of experience in healthcare investment management and entrepreneurship, with in-depth expertise covering the entire industrial chain of healthcare investment, strategic layout and corporate operation. Earlier in her career, she served successively in the Strategy Department of Weihai Group (HK1066) and Biosensors Group (002382), accumulating rich experience in cross-border healthcare industrial cooperation and resource integration. As the Founder of Gluroad Capital, she focuses on healthcare investment banking and equity investment, targeting high-growth tracks including innovative drugs and medical devices. To date, she has supported hundreds of high-quality healthcare innovative enterprises in completing financing, building an efficient connection bridge between industrial capital and outstanding projects. Ms. Sun specializes in healthcare resource integration, international cooperation and investor relations management. She has long been deeply engaged in the healthcare industrial ecosystem, committed to providing professional capital services for innovative pharmaceutical and medical device enterprises, and empowering their rapid growth and large-scale development.

Bingo WANG

Bingo Wang, Master of Pharmaceutical Engineering from China Pharmaceutical University. Has worked for MNC pharmaceutical, and leading domestic biopharmaceutical enterprises. Currently serves as the Deputy Validation Director of Changchun GenSci Pharmaceutical Co., Ltd., responsible for the validation management of DS and DP processes. Has been dedicated to the field of biological drug cleaning validation for many years, proficient in the full life cycle management of cleaning validation and the implementation of compliance. Participated in numerous internal and external audits and on-site inspections related to FDA, EU, and Chinese GMP regulations. Possesses rich practical experience in the field of Biopharmaceuticals cleaning validation.

Vanessa Fernandes

Vanessa Fernandes is the Quality Project Lead of Plai.qa application. In this role, she is driving the Plai.qa project and is accountable for the appropriate design of simplified & standardized processes by relevant Business Process Owners. Through this role, she is supporting Quality Processes transformation through digitalization. Vanessa Fernandes is a Bio-Industry engineer from EBI school (Cergy Pontoise – France) and joined Sanofi in 2015 as Serialization Business System Owner.

Lan SHI

Lan SHI, currently Director of the Drug Supervision Division, Shanghai Administration for Drug Control. She has previously served in policy, legal affairs and inspection departments.
Her major research fields include drug regulatory policies, marketing authorization holder (MAH) supervision, digital traceability of pharmaceuticals, standards for modern pharmaceutical logistics, classified credit supervision of pharmaceuticals, etc.
She has been awarded the title of Advanced Individual in Legal Publicity and Education of the National Food and Drug Administration System, as well as the First Prize Paper Award at the First National Symposium on Health Legal Theory. She is also a specially invited expert of the National Institute for Food and Drug Administration Education, National Medical Products Administration (NMPA).

Jason Ni

With nearly 40 years of experience in the pharmaceutical industry, including almost 28 years of engineering and equipment management experience at renowned foreign-invested pharmaceutical enterprises. He has extensive practical expertise in frontline equipment maintenance, management and selection, as well as material selection for different systems and operating conditions. He also boasts rich experience in construction quality control for new engineering projects.
He has participated in and led the construction and qualification of multiple projects, and is well-versed in GMP requirements for equipment and facilities in pharmaceutical enterprises. He has been responsible for the entire process of renovation and expansion projects from URS (Room Book) development to completion. In addition, he has accumulated in-depth knowledge of key points and challenges in validation and operation & maintenance.
Over years of project delivery and system (equipment) optimization and improvement, all projects have been completed on schedule with near-zero defects and smoothly handed over for production. He also assisted the company in energy conservation and emission reduction initiatives, which helped the enterprise become the first carbon-neutral factory in China’s pharmaceutical industry in 2021.
Furthermore, he has provided internal training for staff of the Jilin Provincial Drug Inspection Center and numerous domestic and foreign-invested pharmaceutical companies, and has collaborated with many well-known domestic training institutions to deliver lectures and courses.

朱政宇

OT 领域自动化专家，长期专注于精细化工与制药行业自动化体系的整体规划、工程实施及运维管理，在复杂生产环境下的系统集成与运营优化方面拥有丰富实践经验。曾作为霍尼韦尔全球 Tiger 小组核心成员，并担任中国区制药工程经理，亲自参与并带领团队完成了多项具有全球代表性的生物制药 CDMO 及 API CDMO 项目建设，涵盖从概念设计、工程实施到投产与运维支持的全生命周期。在制药自动化、GxP 合规、运营韧性与数字化转型等领域具备深厚的行业洞察与实践积累。

Xu YAN

- Bachelor of Chemistry, School of Pharmacy, Peking University Health Science Center, Certificate of on-the-job MAB from China Europe International Business School.
- 30+ years of quality management experience in foreign pharmaceutical industry. Familiar with GMP, GSP related regulations. Committed to quality regulation advocacy.
- Served as head of quality and production business of Novartis China factory. Worked in factories in Singapore and USA for 3 years
- Extensive experience in quality management of GSK's 3 prescription drug factories in China, including establishment and management of Chinese commercial quality departments, quality system establishment and implementation, quality audit and management, familiar with Chinese quality regulatory compliance requirements and holder system.
- Served two terms as Chairman of RDPAC Quality Group from 2019 to 2024, promoted exchanges and advocacy of quality regulations between industry and regulation, academia, shared international practices, and promoted Chinese regulatory requirements to ensure continuous quality compliance.
- Senior Adjunct Consultant at RDPAC, Vice Chairman of ISPE China Compliance Sub-Committee (2024-2025)

Guoling HE

Ms. Guoling graduated from Chemistry Department of Nankai University with a bachelor degree and Management Science & Engineering Department of Tianjin University with master degree. She has been working for nearly 30 years, in many positions, such as Site Head of Sanofi Minsheng Healthcare Hangzhou and Sanofi Beijing, Head of Sanofi China M&S. She currently serves as Senior Advisor for Sanofi InsuLINK IFB Project, leading strategic initiatives within the GenMed New Insulin Facilities Program. With extensive expertise in pharmaceutical manufacturing & supply management, project development, and global operations, Guoling brings practical insights from managing complex, multi-stakeholder M&S transformations. Her work focuses on building resilient, efficient and compliant manufacturing & supply networks across China and Asia-Pacific markets. Guoling is passionate about leveraging digital innovation and strategic partnerships to address industry challenges and drive operational excellence.

Shanti Marlina Sibuea

Shanti Marlina Sibuea is a seasoned professional with a strong educational background and over 15 years of experience as a GMP Inspector and WHO Temporary Advisor. She earned her PhD in stem cell biology from Monash University, Australia, and holds a Master’s degree in Biopharmaceutical Science from Leiden University, the Netherlands, along with Pharmacy and Apothecary degrees from the University of Indonesia. Throughout her career at the Indonesian FDA (Badan POM), she has led and participated in numerous high-level inspections of ATMPs, vaccines, biosimilars, and sterile pharmaceutical facilities. She is also an experienced speaker at national and international forums, including the PDA Conference, WHO meetings, and the PIC/S Expert Circle, and has served as a trainer in GMP forums and regulatory strengthening programs in countries such as India, China, Papua New Guinea, Thailand, the Philippines, and Malaysia. Her international engagement includes serving as a WHO consultant and expert trainer, supporting regulatory system strengthening, quality assurance, and biopharmaceutical product oversight across various countries.

Raymond ZHANG

Joined Novo Nordisk in 2006, holds Master Degree of Software Engineering and MBA.
20+ years working experience in Manufacturing IT, OT and Automation field of international pharmaceuticals corporation, especially in IT/OT technologies, Computer System Validation, Manufacturing Execution System, IT Compliance & Security and Smart Manufacturing. Rich experience in Manufacturing IT/OT project management and commercial-scale manufacturing IT/OT operation.15+ years working experience in project management and leadership of Manufacturing IT/OT and Automation field in international pharmaceutical corporation. Be familiar with PMP, GAMP, Agile Software Development project management and DevOps in GMP environment.
Rich project management experience in software development/test/validation/release, system integration and IT/OT system implementation in GMP environment. With rich experience on oversea co-operation, successfully accomplished a few international IT/OT projects, including various successful new production line introduction projects, pharma facility projects, automatic warehouse project and Industry 4.0 projects.
As expert in quality compliance management for computer systems in pharmaceutical enterprise. Especially deep understanding and using GxP regulation, 21 CFR Part 11, GAMP5, CSV, COBIT and IT Security to ensure compliance requirements for pharmaceutical enterprise.
As expert of pharmaceuticals manufacturing area to drive digital innovation and Smart Manufacturing/Industry 4.0 initiatives. As Pharma MES member and speaker, MESA International member and Yeehongedu Professor.

Douglas B. Hausner, PhD

Douglas B. Hausner, PhD, is currently a Life Sciences SME/OSD Specialist at CRB. He brings more than a decade of pharmaceutical process experience to help lead complex large scale customer programs. He has been an ISPE member since 2011.

Xiaofeng SUN

Sun Xiaofeng holds a Master's degree in Mechanical Engineering from Hohai University and is a Senior Engineer. He currently serves as Deputy General Manager of Shandong Weigao Pury Pharmaceutical Packaging Co., Ltd., and concurrently as General Manager of the Injection Pen Division, where he is responsible for the company's R&D strategy formulation and industrialization advancement in the fields of pre-filled syringes and drug delivery devices.With over a decade of experience in the pharmaceutical packaging and medical device industry, he has long focused on the R&D and engineering translation of drug-device combination products, possessing full lifecycle management experience from product definition and design development to mass production introduction.In the technical domain, he has led the R&D and industrialization of key technologies such as precision drive mechanisms for auto-injector pens and multi-dose delivery control. He holds multiple domestic and international invention patents (including core patents related to auto-injector pens and adjustable-dose injection pens) and has led the domestic standardization and adoption of ISO 11608-5.In terms of R&D management and industrialization, he has driven the establishment of an engineering-deterministic-oriented R&D system, promoted the platform-based development and large-scale manufacturing of pre-filled syringe and injection pen products, and supported the company in maintaining a leading position in China's pharmaceutical packaging and drug delivery system field.Since assuming the concurrent role of General Manager of the Injection Pen subsidiary, he has further promoted the deep integration of R&D and manufacturing, achieving systemic capability building for high-end drug delivery devices from conceptual design to commercial launch.

Kirk XU

Harbin Institute of Technology and a master’s degree from Renmin University of China, currently serves as Deputy General Manager of Sales & Marketing at Huber-Ranner and Person-in-Charge of KVS business.
With 19 years of in-depth experience in the HVAC industry, he oversees market operation and the implementation of large-scale purified HVAC projects. He has led key engineering constructions for biomedicine and medical laboratories and holds patents related to HVAC equipment.
He once led the purified air conditioning support work for Huoshenshan Hospital. Dedicated to research on energy-saving technologies for clean air conditioning, he is a senior professional in the pharmaceutical and medical HVAC field with outstanding practical and technical industry influence.

Shengliang CUI

Mr. Cui Shengliang earned his Bachelor of Science in Organic Chemistry from the Department of Chemistry, Lanzhou University, and his Master of Engineering in Biochemical Engineering from the Department of Chemical Engineering, Tsinghua University.

He is currently working at Novartis China, in charge of supply chain planning, warehousing and logistics, as well as import and export businesses for Novartis Greater China.

With over 20 years of professional experience in multinational pharmaceutical enterprises, Mr. Cui has extensive expertise in production and operation, financial management, procurement and supply chain management.

Ian Thrussell

Providing expert inspection, audit , consultancy and training services to National Regulatory Agencies and IGOs. Clients have included WHO, Maltese Medicines Authority, CDFA, PATH, Bill and Melinda Gates Foundation and International Committee of the Red Cross. Based in Nottingham in the UK and in Geneva, Switzerland.
• During 2020 - 2022 based in Shanghai providing advice on GMP projects for Covid and HPV vaccines.
• Over 25 Years Experience in GMP Regulatory Inspection for Authorities at both national and international level and 18 years of industrial experience gained in the management of development, technical support and validation, quality and regulatory roles in the Pharmaceutical and Medical Device Industries, prior to joining MCA primarily in sterile product R&D, manufacturing, RA and QA.
• Chartered Chemist and a Fellow of the Royal Society of Chemistry of Great Britain. Eligible to act as a Qualified Person in the EU. Worked for over 10 years as an EU QP releasing product to market in the EU
• Retired from WHO as Head of Prequalification Inspection Services in November 2016. Previously GMP Expert Inspector to the Inspection Services Group of the consolidated WHO Prequalification Team for Medicines, Vaccines, Devices and Diagnostics and from October 2013 2016 Head of inspections of Medicines, WHO Geneva 2011 – 2013. Was the lead author of the WHO guidance on
Good Data and record management.
• In 1994 joined the GMP Inspectorate of the then UK MCA (Medicines Control Agency) and immediately before moving to Geneva, was one of the UK MHRA GMP Inspectorate Expert Inspectors, a member of the GMP Inspectorate’s Strategic Group with the responsibility of representing the UK Agency’s GMP interests at the European Medicines Agency Inspectors Working Group.
• Has conducted over 500 inspections in UK and over 1000 inspections in 38 other countries including USA, Japan, India and China.
• Conducted audits for BFGF/Chinese FDA of provincial Inspection systems 2014-2018
• Member of the EU Regulatory team for ICH Q10, Quality Systems
• Assessor and Rapporteur for accession of several Inspectorates to PIC/s
• A tutor and trainer at many EU, PIC/s, MHRA and WHO organised GMP
training symposia in Africa, China, India for Industry as well as those for CMC assessment and inspection personnel of National Medicines Regulatory Authorities.
• A visiting lecturer to the Masters Course in Pharma Regulatory Affaires, Peking University

Shanti Marlina Sibuea

Shanti Marlina Sibuea is a seasoned professional with a strong educational background and over 15 years of experience as a GMP Inspector and WHO Temporary Advisor. She earned her PhD in stem cell biology from Monash University, Australia, and holds a Master’s degree in Biopharmaceutical Science from Leiden University, the Netherlands, along with Pharmacy and Apothecary degrees from the University of Indonesia. Throughout her career at the Indonesian FDA (Badan POM), she has led and participated in numerous high-level inspections of ATMPs, vaccines, biosimilars, and sterile pharmaceutical facilities. She is also an experienced speaker at national and international forums, including the PDA Conference, WHO meetings, and the PIC/S Expert Circle, and has served as a trainer in GMP forums and regulatory strengthening programs in countries such as India, China, Papua New Guinea, Thailand, the Philippines, and Malaysia. Her international engagement includes serving as a WHO consultant and expert trainer, supporting regulatory system strengthening, quality assurance, and biopharmaceutical product oversight across various countries.

Tuukka MUSTAPÄÄ

Tuukka Mustapää, D.Sc. (Tech.) in Mechanical Engineering from Aalto University, Finland, is currently working as a Product Owner of DCC at Beamex. He has a strong background in digitalization of metrology through his research and involvement in several development projects and standardization working groups. From 2018 onwards his work as a researcher and technological expert in the industry has focused on leveraging emerging new standards and technologies such as the Digital Calibration Certificate (DCC) in improving and optimizing industrial calibration processes and calibration management. Starting from April 2023 he has been a requirements specialist and product owner for DCC at Beamex providing his expertise for the adoption of the DCC and taking the technology from a concept into a production-ready solution for the industry.

Paige E. Kane

Paige Kane PhD, CPIP, Is the Associate Vice President of Operational Readiness/Excellence at CAI. She is an industry leader with over 30 years’ experience across the pharmaceutical Lifecyle from R&D through manufacturing at MSD, Pfizer, Genetics Institute, Wyeth, and Monsanto. In addition to her 15 years in the field of Knowledge Management, Operational Excellence, and Global Strategy development, she has led Quality Systems Groups focusing on Automation Compliance, Data Integrity, Computer Validation, and Change Control during startup and operations for biologics facilities in the US and Ireland.
Dr. Kane has been a ISPE member for over 20 years, frequently contributing to ISPE GPG teams including the Pharm 4.0 Baseline Guide, the Knowledge Management guide and multiple GAMP guides. She previously led the ISPE Global Biotech CoP and Americas/EU GAMP regional CoPs. Kane holds a PhD in Pharmaceutical and Regulatory Science from Technical University Dublin (Dublin, Ireland). She is frequent industry author and presenter and continues her research as a member of the TU Dublin Pharmaceutical Regulatory Sciences Team (PRST).

Jian YE

A graduate in Pharmacy from China Pharmaceutical University, he currently serves as Senior Manager of the Equipment Department and Manager of the Capacity Expansion Project Department at Shanghai RAAS Blood Products Co., Ltd. He leads the company’s daily operations and maintenance, equipment management empowerment for various production bases, and the construction of a new 35-meter-high, 70,000+ square meter capacity expansion project. With over 20 years of experience in the biologics industry, his career began in production management at Shanghai RAAS, followed by a tenure at a leading domestic pharmaceutical equipment manufacturer, before returning to Shanghai RAAS in 2021. He is proficient in upstream and downstream process design, sterile formulation facility design (SVP lines, lyophilization lines, BFS, PFS), and equipment lifecycle management, and holds a PMP certification. Leveraging his dual perspective from both production operations (Party A) and equipment design/manufacturing (Party B), he has successfully delivered multiple major facility projects, driving the establishment of a digitalized equipment lifecycle management system through rigorous project management practices and systematic training empowerment, significantly enhancing team capabilities and operational efficiency.

Oliver Herrmann

Mr. Oliver Hermann, founder and CEO of QFINITY, is an internationally acknowledged expert on validation, technology quality, data integrity and system implementation. His extensive knowledge, expertise, and unwavering energy and passion have enabled him to become a key contributor to the ISPE GAMP organization. Oliver has led the international Special Interest Group and co-authored a GAMP Good Practice Guide for Clinical Systems. Oliver is the Chair of the GAMP DACH organization and thereby becoming a driving force for the GAMP Community in Germany, Austria and Switzerland. He is a member of the GAMP EU Steering Committee and the GAMP Global Steering Committee of the ISPE GAMP COP to help shape the future of validation and data concepts.

Jeffery N. Odum

Jeff Odum’s career encompasses over 30 years of experience in the development, execution, delivery, and management of facility and operational programs in the biotechnology and pharmaceutical industries. During his career, he has been involved in leading and managing strategic planning, feasibility and conceptual planning/design, design, construction, start-up, and validation support, in addition to participating in the development and presentation of licensing packages to the FDA. Specific responsibilities have included positions as Global Lead, Operations Director, Design Manager, Facility/Engineering Manager, Owner’s Representative, Program Manager, and Construction Site Manager for projects focused on the manufacture of human therapeutics including vaccines, cancer therapeutics, generics, and ATMPs. These efforts ranged in size from $1 million to more than $2 billion in total program costs.
Jeff was the North American Education Advisor to ISPE, where he also is currently the Chair of the Global Biotechnology Community of Practice and the Project Lead for the ATMP Guide for Autologous Cell Therapy Products, co-Lead for the new revision of the Biotech Manufacturing Facilities Baseline Guide, chapter author for the Biotech Product and Process Development Baseline Guide, and a lead author for the BPOG Closed Systems Closure Playbook. He has written over 50 Technical articles and published four Industry reference books.
He is a member of the BTEC teaching faculty in NC State University’s Gradute program in Biomanufacturing.

Richard Chai

As a Senior Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical support and training to customers related to contamination control for cleanrooms, process equipment cleaning process and sterility assurance & maintenance. He is also a frequent industry speaker at industry events such as ISPE and PDA, and he is also a qualified ISPE trainer for ‘Cleaning Validation Principles Training Course’. Richard has more than 25 years of pharmaceutical industry experience in manufacturing, validation, consultancy and technical support.

Jintao GUO

IT Director of Hualan Biological Vaccine Inc

Tracy YU

Tracy Yu, graduated from Beihang University with a degree in Industrial Foreign Trade & Aeronautical Technology and obtained a Master’s degree in International Trade from Shanghai University of International Business and Economics. With more than 20 years of experience in the pharmaceutical industry, she has worked for APL Logistics, and then multiple European MNC ,including Grünenthal, GSK, and Ipsen. Her expertise spans end-to-end supply chain management, including demand planning, production supply, packaging and serialization, warehousing, and distribution management. She has held leadership roles such as China Supply Chain Director and Regional Supply Planning Director for Southeast Asia, with experience across a broad portfolio covering skincare products, OTC products, general medicines, specialty medicines, and vaccines.

FRANCES ZIPP

Fran Zipp is President & CEO of Lachman Consultant Services, Inc. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements and delivers strategic guidance and direction toward implementation of effective solutions to client needs. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, and Due Diligence evaluations (facilities; products; technologies).

ANDREW (ANDY) HOPKINS

Andrew’s expertise spans GMP inspection readiness, multinational regulatory inspections, sterile manufacturing (including aseptic processing and terminal sterilization), pharmaceutical quality systems, microbial laboratory operations, environmental monitoring risk assessment, and new facility design. He is frequently sought after for his ability to guide organizations through FDA and global regulatory remediation, pre‑approval inspections, and due‑diligence evaluations.
 
Andrew is an active contributor to professional organizations, including the Parenteral Drug Association (PDA), where he serves on the Board of Directors and has participated in technical report working groups (TR1, TR13, TR90). He is also a member of PHSS and PHARMIG.
 
He holds a Postgraduate Diploma in Industrial Pharmaceutical Science from Brighton University, a Bachelor of Science in Microbiology with Genetics from the University of Wales, and an HNC in Applied Science.

Hua FANG

Fang Hua graduated from East China University of Science and Technology with a bachelor's degree in Pharmaceutical Engineering. Currently, he serves as the head of the Engineering Service Center at CanSino Biologics Inc., mainly responsible for the planning and implementation management of the company's fixed asset construction projects.
With 25 years of experience in pharmaceutical factory engineering project management, he has an in-depth understanding of the entire engineering project life cycle, from project initiation, design, procurement, construction, validation to delivery. He has successfully delivered a variety of pharmaceutical process workshops and industrial park planning, including biopharmaceuticals, sterile filling, R&D buildings, solid preparations, and APIs.
In his career, he has held senior management positions in technology and project management in many industry-leading enterprises such as Sinopec Shanghai Engineering Co., Ltd., Roche Pharmaceuticals, and Shanghai Pharmaceutical Group. Since September 2021, he has served at CanSino Biologics Inc., leading the team to deliver approximately 120,000 square meters of production plants and R&D centers.

Xu YAN

- Bachelor of Chemistry, School of Pharmacy, Peking University Health Science Center, Certificate of on-the-job MAB from China Europe International Business School.
- 30+ years of quality management experience in foreign pharmaceutical industry. Familiar with GMP, GSP related regulations. Committed to quality regulation advocacy.
- Served as head of quality and production business of Novartis China factory. Worked in factories in Singapore and USA for 3 years
- Extensive experience in quality management of GSK's 3 prescription drug factories in China, including establishment and management of Chinese commercial quality departments, quality system establishment and implementation, quality audit and management, familiar with Chinese quality regulatory compliance requirements and holder system.
- Served two terms as Chairman of RDPAC Quality Group from 2019 to 2024, promoted exchanges and advocacy of quality regulations between industry and regulation, academia, shared international practices, and promoted Chinese regulatory requirements to ensure continuous quality compliance.
- Senior Adjunct Consultant at RDPAC, Vice Chairman of ISPE China Compliance Sub-Committee (2024-2025)

Shuting XU

Hui WANG

With nearly three decades of international experience across technical, commercial and management roles in APAC, Europe and the Middle East, Hui focuses on deploying engineering-grade process digital twins in life sciences and broader process industry applications. From R&D to manufacturing, not just a model but an engineering-grade decision engine.

Ruqaya Al Bastaki

Dr Ruqaya Albastaki, a senior regulatory leader in the United Arab Emirates, has extensive experience in the pharmaceutical and medical products regulatory sector, She previously served as the Director of the Drug Department at MOHAP, where she led multiple key divisions responsible for regulating medical products, including the Import and Export of Medical Products and Precursor Chemicals, the Quality Control Laboratory for Medical Products, as well as the Drug Registration and Pharmacovigilance divisions.
She currently serves as the Medical Products Regulations Sector Lead at the Emirates Drug Establishment (EDE), where she oversees the strategic direction and governance of regulatory frameworks across the UAE. In this role, she is committed to advancing regulatory excellence, strengthening lifecycle oversight, and enabling timely access to safe, high-quality, and innovative medical products.
Dr Albastaki has been instrumental in driving transformative initiatives that have significantly enhanced the efficiency, agility, and effectiveness of the regulatory system, She possesses deep expertise across the full regulatory lifecycle and plays a key role in shaping policies that align with international best practices.
Through her visionary leadership and dedication to public health, she continues to contribute to the evolution of pharmaceutical regulation in the UAE, reinforcing the country’s position as a regional leader in regulatory innovation and healthcare advancement.

Martin Heitmann

Martin Heitmann is a trained business mathematician and serves as consultant and advisor to organizations in the Life Sciences. He holds a decade of experience focusing on technology, innovation, and transformation. He drives progress and inspires excellence in life sciences, while supporting to maintain compliance and promote quality. He serves as Secretary of the GAMP Global Software Automation and AI Special Interest Group and co-led the ISPE GAMP AI Guide Initiative.

Julia Schmitz

Julia Schmitz is the Head of Global Software Integration at Körber Pharma Software, where she leads the AI Development Team. She drives the strategic and operational development of GxP‑compliant, cloud‑based AI products for the pharmaceutical industry. With a strong background in software engineering and regulated pharma environments, she focuses on advancing secure and innovative AI capabilities for major global pharma and biotech companies while aligning teams, processes, and quality standards across the organization.

Yang ZHAO

With nearly 15 years of experience in the biopharmaceutical industry, Yang ZHAO has built a distinguished career spanning technology transfer, project management, and business development at leading global and domestic pharmaceutical companies, including Eli Lilly, GenSci, and TopAlliance. Maintaining strong partnerships with top-tier international and domestic service providers and suppliers, Zhao has successfully established multiple biological laboratories, completed the construction of two pilot plants, and led the process design and construction of two commercial-scale manufacturing facilities.As an active contributor to the field, Yang ZHAO frequently shares technical insights and achievements at major industry conferences and has played a key role in formulating and publishing industry standards. Yang Zhao possesses extensive expertise in biopharmaceutical R&D, technology in-licensing and transfer, cleanroom process design, and comprehensive project management.

Ziran TANG

Joined WuXi Biologics in 2011, bringing 17 years of specialized experience in cell culture process development. Demonstrated expertise across early- and late-phase projects with strong technical proficiency in perfusion and fed-batch culture systems. Successfully led GMP manufacturing digital transformation initiatives and currently oversee the implementation of a fully automated, end-to-end disposable continuous manufacturing platform at MFG17.

Noura Abdelaal

ANDREW (ANDY) HOPKINS

Andrew’s expertise spans GMP inspection readiness, multinational regulatory inspections, sterile manufacturing (including aseptic processing and terminal sterilization), pharmaceutical quality systems, microbial laboratory operations, environmental monitoring risk assessment, and new facility design. He is frequently sought after for his ability to guide organizations through FDA and global regulatory remediation, pre‑approval inspections, and due‑diligence evaluations.
 
Andrew is an active contributor to professional organizations, including the Parenteral Drug Association (PDA), where he serves on the Board of Directors and has participated in technical report working groups (TR1, TR13, TR90). He is also a member of PHSS and PHARMIG.
 
He holds a Postgraduate Diploma in Industrial Pharmaceutical Science from Brighton University, a Bachelor of Science in Microbiology with Genetics from the University of Wales, and an HNC in Applied Science.

Chong hock Sia

Mr. Sia Chong Hock has been the Director of Quality Assurance and Senior Consultant of Audit and Licensing at the Singapore Health Sciences Authority (HSA) since 2015, where he was previously the Director of the Audit and Licensing Division in the period 2008 to 2015. From 1995 to 2022, he was also an Adjunct Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS). He had been a member of the Singapore Pharmacy Council and its predecessor Singapore Pharmacy Board from 2002 to 2018, including being the Chair of its Complaints Panel. He holds a Bachelor’s degree in Pharmacy from NUS, as well as a Master’s degree in Healthcare Management (with Distinction) from the University of Wales, UK.
Mr. Sia has played a monumental role in, and won several awards for, shaping Singapore to be a world leader in pharmaceutical regulation. He took up the challenge to set up the GMP Audit Unit and led Singapore to become the first Asian member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2000, and was subsequently appointed Chair of the ASEAN MRA Task Force and Joint Sectoral Committee on GMP Inspection from 2005 to 2020. In 2013, he was conferred the Industry Pharmacist of the Year Award by the Pharmaceutical Society of Singapore, and in 2016, he was honored with the International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Affiliate Lifetime Achievement Award for his contributions to the field of Pharmaceutical Regulatory Practices in Singapore and the ASEAN region. More recently, he was a recipient of the PS (Health) Award 2023 for his key role as a core team member responsible for HSA being the first National Regulatory Authority (NRA) in the world to achieve Maturity Level 4 under the World Health Organization Global Benchmarking Tools (WHO GBT) assessment. This WHO GBT certification confirms HSA as an NRA that is operating at an advanced level of regulation in medicinal products and vaccines. On the academic front, he contributes review articles regularly to international scientific journals, covering the regulation of pharmaceuticals and biopharmaceuticals. In 2016 and 2019, two of his articles won the ISPE Roger Sherwood Article of the Year Award.

Shanti Marlina Sibuea

Shanti Marlina Sibuea is a seasoned professional with a strong educational background and over 15 years of experience as a GMP Inspector and WHO Temporary Advisor. She earned her PhD in stem cell biology from Monash University, Australia, and holds a Master’s degree in Biopharmaceutical Science from Leiden University, the Netherlands, along with Pharmacy and Apothecary degrees from the University of Indonesia. Throughout her career at the Indonesian FDA (Badan POM), she has led and participated in numerous high-level inspections of ATMPs, vaccines, biosimilars, and sterile pharmaceutical facilities. She is also an experienced speaker at national and international forums, including the PDA Conference, WHO meetings, and the PIC/S Expert Circle, and has served as a trainer in GMP forums and regulatory strengthening programs in countries such as India, China, Papua New Guinea, Thailand, the Philippines, and Malaysia. Her international engagement includes serving as a WHO consultant and expert trainer, supporting regulatory system strengthening, quality assurance, and biopharmaceutical product oversight across various countries.

Ian Thrussell

Providing expert inspection, audit , consultancy and training services to National Regulatory Agencies and IGOs. Clients have included WHO, Maltese Medicines Authority, CDFA, PATH, Bill and Melinda Gates Foundation and International Committee of the Red Cross. Based in Nottingham in the UK and in Geneva, Switzerland.
• During 2020 - 2022 based in Shanghai providing advice on GMP projects for Covid and HPV vaccines.
• Over 25 Years Experience in GMP Regulatory Inspection for Authorities at both national and international level and 18 years of industrial experience gained in the management of development, technical support and validation, quality and regulatory roles in the Pharmaceutical and Medical Device Industries, prior to joining MCA primarily in sterile product R&D, manufacturing, RA and QA.
• Chartered Chemist and a Fellow of the Royal Society of Chemistry of Great Britain. Eligible to act as a Qualified Person in the EU. Worked for over 10 years as an EU QP releasing product to market in the EU
• Retired from WHO as Head of Prequalification Inspection Services in November 2016. Previously GMP Expert Inspector to the Inspection Services Group of the consolidated WHO Prequalification Team for Medicines, Vaccines, Devices and Diagnostics and from October 2013 2016 Head of inspections of Medicines, WHO Geneva 2011 – 2013. Was the lead author of the WHO guidance on
Good Data and record management.
• In 1994 joined the GMP Inspectorate of the then UK MCA (Medicines Control Agency) and immediately before moving to Geneva, was one of the UK MHRA GMP Inspectorate Expert Inspectors, a member of the GMP Inspectorate’s Strategic Group with the responsibility of representing the UK Agency’s GMP interests at the European Medicines Agency Inspectors Working Group.
• Has conducted over 500 inspections in UK and over 1000 inspections in 38 other countries including USA, Japan, India and China.
• Conducted audits for BFGF/Chinese FDA of provincial Inspection systems 2014-2018
• Member of the EU Regulatory team for ICH Q10, Quality Systems
• Assessor and Rapporteur for accession of several Inspectorates to PIC/s
• A tutor and trainer at many EU, PIC/s, MHRA and WHO organised GMP
training symposia in Africa, China, India for Industry as well as those for CMC assessment and inspection personnel of National Medicines Regulatory Authorities.
• A visiting lecturer to the Masters Course in Pharma Regulatory Affaires, Peking University

FRANCES ZIPP

Fran Zipp is President & CEO of Lachman Consultant Services, Inc. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements and delivers strategic guidance and direction toward implementation of effective solutions to client needs. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, and Due Diligence evaluations (facilities; products; technologies).

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy.
Holding an M.Sc. in Biochemical Engineering from the University of Birmingham, Shanshan brings 18 years of global experience across consulting firms and pharmaceutical giants like Novartis, focusing on process, quality, compliance, and regulatory areas.
Shanshan is passionate about connecting people and technologies in the life science industry and is devoted to fostering international collaborations. She currently serves on the ISPE International Board, contributing to its global mission and vision.

Raymond ZHANG

Joined Novo Nordisk in 2006, holds Master Degree of Software Engineering and MBA.
20+ years working experience in Manufacturing IT, OT and Automation field of international pharmaceuticals corporation, especially in IT/OT technologies, Computer System Validation, Manufacturing Execution System, IT Compliance & Security and Smart Manufacturing. Rich experience in Manufacturing IT/OT project management and commercial-scale manufacturing IT/OT operation.15+ years working experience in project management and leadership of Manufacturing IT/OT and Automation field in international pharmaceutical corporation. Be familiar with PMP, GAMP, Agile Software Development project management and DevOps in GMP environment.
Rich project management experience in software development/test/validation/release, system integration and IT/OT system implementation in GMP environment. With rich experience on oversea co-operation, successfully accomplished a few international IT/OT projects, including various successful new production line introduction projects, pharma facility projects, automatic warehouse project and Industry 4.0 projects.
As expert in quality compliance management for computer systems in pharmaceutical enterprise. Especially deep understanding and using GxP regulation, 21 CFR Part 11, GAMP5, CSV, COBIT and IT Security to ensure compliance requirements for pharmaceutical enterprise.
As expert of pharmaceuticals manufacturing area to drive digital innovation and Smart Manufacturing/Industry 4.0 initiatives. As Pharma MES member and speaker, MESA International member and Yeehongedu Professor.

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技(上海)有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于寻找新的商业机会，以实现销售和服务的快速扩展。他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有深入的理解，是生产数字化转型领域的权威专家。在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自2019年3月起，他开始在柯尔柏医药科技中国区担任董事总经理。他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China University of Science and Technology, currently serves as the Managing Director of Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs of the Körber Business Area Pharma in China, committed to seeking new business opportunities to achieve rapid expansion of sales and services. He has more than twenty years of profound experience in the life sciences industry particularly in areas such as research and development, production, pilot production processes, production equipment, and automation hardware and software. He has an in-depth understanding of the entire process of the pharmaceutical and biotechnology industry, as well as is an authoritative expert in the field of digital transformation in production. During Jerry's career, he has held senior management positions in technology, sales, and business development in several industry-leading companies such as Harro Hofiger and Rockwell Automation. He has been recognized multiple times for his outstanding performance. Since March 2019, he has been serving as the Managing Director of Körber Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully formulated and implemented the company's strategic goals, leading the team to achieve breakthrough development, thereby further expanding the company's sales and market influence in China.

Huilin ZHU

Head of Clinical Manufacturing at WuXi Biologics, with 15 years of experience in the biopharmaceutical industry.
Supervising a clinical manufacture network with cell banking and drug substance GMP facilities operating at multiple sites, to deliver DS with global quality standards.
Deep expertise spanning cell culture process development, DS technology transfer & scale-up, pilot production , GMP manufacturing and quality management.
Multiple years of end to end CMC lifecycle management of biopharmaceutical products with modalities encompassing mAb, bsAb and ADC.
Core member of ISPE China Biologics Process and Production sub-committee since 2022. Led planning and execution of ISPE activities including ISPE China Annual Meetings, online and offline sub-committee activities.

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技(上海)有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于寻找新的商业机会，以实现销售和服务的快速扩展。他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有深入的理解，是生产数字化转型领域的权威专家。在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自2019年3月起，他开始在柯尔柏医药科技中国区担任董事总经理。他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China University of Science and Technology, currently serves as the Managing Director of Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs of the Körber Business Area Pharma in China, committed to seeking new business opportunities to achieve rapid expansion of sales and services. He has more than twenty years of profound experience in the life sciences industry particularly in areas such as research and development, production, pilot production processes, production equipment, and automation hardware and software. He has an in-depth understanding of the entire process of the pharmaceutical and biotechnology industry, as well as is an authoritative expert in the field of digital transformation in production. During Jerry's career, he has held senior management positions in technology, sales, and business development in several industry-leading companies such as Harro Hofiger and Rockwell Automation. He has been recognized multiple times for his outstanding performance. Since March 2019, he has been serving as the Managing Director of Körber Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully formulated and implemented the company's strategic goals, leading the team to achieve breakthrough development, thereby further expanding the company's sales and market influence in China.

Mark Hernick

马 Marcus