华玉涛

曾担任科技部中国生物技术发展中心化学药与医疗器械处处长、生物资源与安全处处长等职务，2019年经中组部选派至海南省卫健委任规划发展与信息化处处长，现任上海碧博生物副总裁。曾参与起草“重大新药创制”科技重大专项实施方案及实施计划；参与起草科技部生物医药领域、医疗器械领域相关规划；参与《国家生物技术发展战略纲要》编制；主持《人类遗传资源管理条例实施细则》修改、海南卫生健康“十四五”规划编制等。有丰富的战略规划、政策制定及企业管理经验。
华玉涛毕业于清华大学，获得微生物硕士学位。

John Lepore

John Lepore is an industry consultant specializing in small molecule process development, development quality systems, and regulatory strategy. Prior to his retirement from Merck (MSD) John Lepore was CMC and QbD practices lead for small molecules and led API process development for Merck synthetic compounds. In this role, he was responsible for process definition and optimization, including the application of appropriate phenomenological and empirical models with the goal of gaining technical understanding of API chemical processes, and enabling a science and risk based approach to API process development. During his 32-year career with Merck, John has led the API launch of nine products, operation of pilot plant facilities at Rahway, and the compliance function, encompassing safety, environmental, and GMP areas. With an in-depth knowledge of drug development and process and product economics, Dr. Lepore is a regular instructor for training of FDA staff (ORA), and a guest lecturer at both the University of Michigan (Pharmaceutical Engineering Program), and Rutgers University (Lerner Center for Pharmaceutical Management Studies). He serves on the ISPE PQLI Technical Steering Committee and was Chair of the Design Space Task Team. John received a Ph.D in Chemical and Biochemical Engineering at Rutgers University in New Brunswick, NJ, and a BS degree in Chemical Engineering from Worcester Polytechnic Institute.

高杨 博士

高杨博士目前担任上海邦耀生物科技有限公司的首席战略官，全面负责公司基因和细胞治疗产品的开发、申报、项目资产管理等工作，协助CEO整个公司的经营
加入上海邦耀生物科技有限公司之前，高博士在制药行业拥有近20年的管理和开发经验，先后在国家药品监管机构、跨国制药企业、生物科技公司和全球CRO公司担任技术/管理工作，熟悉制药行业全链条的运转之道，尤其在药物开发策略、申报策略、质量体系建设和商业化战略方面有着全面、丰富的经验。曾是中国国家药品监督管理局药品审评中心的高级审评官，8年时间内审评过千份申报项目并执行过几十次现场检查，涵盖跨适应症领域的新药临床申请、新药上市申请、仿制药申请、上市后补充申请等技术审评工作，对监管科学和CDE、FDA、EMA及ICH的技术指南有着全面深刻的理解。之后4年担任礼来公司的法规CMC和医疗器械负责人，领导多个创新药CMC策略、技术转移策略和医疗器械注册策略的制定和执行，参与礼来全球加快研发的改革工作，并为礼来在华合作伙伴的创新药研发和商业化提供技术支持。同期兼任RDPAC的CMC委员会轮值主席，领导7个工作组为2015年启动的中国药监改革积极建言献策，为构建支持药物创新的新生态系统做出了杰出贡献。曾担任苏州亚盛制药的法规事务总监，制定并执行中美研发和注册策略，成功获批中、美多个IND。之后担任PAREXEL的首席药物研发和法规顾问，3年时间内为多达30家国内外生物制药公司约50个项目提供研发和监管策略的咨询服务，成功助力他们在中美获得监管部门的批准并开展新药研发。业余时间，高博士积极探索和实践人工智能和数字技术赋能药物研发，设计并开发远程智能化临床试验平台。

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. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

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.

郑磊明

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,
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 Höfliger 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.

王卫兵

王博士从事医药行业30多年，包括药品研发分析，质量管理和生产运营管理。熟悉从实验室管理，到质量体系建设与运行，集团化企业质量管理等，多次主持通过美、欧、日、WHO等世界各国/组织针对原料药与制剂的现场检查，包括原料药（含无菌原料药），口服制剂，注射剂，涵盖人用药及兽药。熟悉国内外法规，并有多年实践经验。2010版药品GMP指南编委。
王博士先后在多家国内大型企业，国际跨国公司任职，担任质量负责人，目前任江苏恩华药业副总裁，负责企业整体生产质量运营工作。

Vivien Santillan

Vivien Santillan 女士是 Novatek International 的亚洲区域总监和项目顾问，该公司是一家总部位于加拿大的生命科学 IT 公司，提供符合监管要求的软件解决方案，服务于制药、生物技术及其他医疗保健行业。
Vivien 曾担任 ISPE 菲律宾分部主席（2017-2020）和亚太委员会主席（2019-2020），也是多个ISPE 实践社区（COP）指导委员会的成员，如药品短缺倡议团队和质量控制/分析小组。她目前是 ISPE 女性制药国际指导委员会的主席，以及 ISPE GAMP 南亚小组的联席主席。Vivien 在计算机系统验证、数据完整性、污染控制策略、数字化及其他行业和监管相关主题上进行演讲和培训。
作为一名杰出的技术销售总监、业务发展和市场营销专业人士，Vivien 在信息技术和服务行业拥有超过 25 年的经验。在过去 17 年里，她一直在帮助制药公司实现监管合规，提供技术支持、差距分析、计算机系统验证、文档及 LIMS、数字化质量管理系统和污染控制解决方案的实施和使用培训。她毕业于德拉萨大学，获得计算机应用学位，并持有全面质量管理（TQM）认证。

Mark Hernick

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

张平

张平，现任海普瑞全球工业事务高级副总裁，拥有（MBA）学位以及跨国工作及学习经历。曾担任赛诺菲工业事务部中国区负责人，负责赛诺菲中国区工业运营，牵头多个新产品及集团产品转移项目在中国落地。在此之前，他曾就职于中国第一批外商投资企业-西安杨森制药公司。张平具有30多年外资企业药品生产管理方面的经验，并获得了国内第一批六西格玛黑带认证。

华玉涛

曾担任科技部中国生物技术发展中心化学药与医疗器械处处长、生物资源与安全处处长等职务，2019年经中组部选派至海南省卫健委任规划发展与信息化处处长，现任上海碧博生物副总裁。曾参与起草“重大新药创制”科技重大专项实施方案及实施计划；参与起草科技部生物医药领域、医疗器械领域相关规划；参与《国家生物技术发展战略纲要》编制；主持《人类遗传资源管理条例实施细则》修改、海南卫生健康“十四五”规划编制等。有丰富的战略规划、政策制定及企业管理经验。
华玉涛毕业于清华大学，获得微生物硕士学位。

Norman Goldschmidt

Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) Author/Expert, Adjunct Professor at the New Jersey Institute of Technology, Lead/Contributing Author on 8 ISPE Guides well as author, contributor and instructor for ISPE, ASHRAE, NSF, FDA, HCA, TGA and others.

王卫兵

王博士从事医药行业30多年，包括药品研发分析，质量管理和生产运营管理。熟悉从实验室管理，到质量体系建设与运行，集团化企业质量管理等，多次主持通过美、欧、日、WHO等世界各国/组织针对原料药与制剂的现场检查，包括原料药（含无菌原料药），口服制剂，注射剂，涵盖人用药及兽药。熟悉国内外法规，并有多年实践经验。2010版药品GMP指南编委。
王博士先后在多家国内大型企业，国际跨国公司任职，担任质量负责人，目前任江苏恩华药业副总裁，负责企业整体生产质量运营工作。

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. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Maurice B. Parlane

Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE’s Asia Pacific Regulatory and Quality Harmonization committee and leader of the Process Validation Team and is a member of the Guidance Documents Committee. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016. He is currently serving as the Leader of the ISPE Process Validation Team.

Fritz Röder

Fritz Roeder is Director - Site Account Engineer at Merck Healthcare KGaA in Germany. He has over 15 years of broad experience in pharmaceutical manufacturing in engineering, quality, project managment and other fields. Fritz is a frequent speaker at events and author of various books, articles and ISPE guides on pharmaceutical topics. Fritz is also serving as current ISPE Chair of the Critical Utilities Steering Committee and as a member at the water group at "EDQM" which is maintaining the European Water Monographs.

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。

张秀芹

张秀芹博士从事生物制药行业近20年，工作重点涵盖生物大分子药物原液生产工艺开发、工艺放大、技术转移及GMP生产管理等方面。带领团队成功完成近500批原液GMP生产，在工艺放大风险管理、生产管理、质量提升、共线生产管理及污染与交叉污染控制方面具备丰富的实践经验.。张秀芹博士于2012年加入上海药明生物技术有限公司，现担任原液生产三厂生产负责人。

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.

杨晓林

杨晓林自1998年开始致力于净化空调系统动态稳定的自控研究，深耕医药净化系统设计、施工管理、咨询等工作20多年，具有丰富的项目设计、咨询和管理经验，在行业倡导性提出“动态复杂空调系统”以应对医药企业常见的净化空调系统问题，并擅长“动态稳定，合规降本”理念在医药净化系统新、改建项目的落地应用，承担过不同规模不同剂型（口服、注射、生物等）的上百个项目新改建。

罗仁豪

罗仁豪先生在生物制药行业拥有25年以上的工作经验, 先后服务过先灵葆雅, 基因泰克/罗氏（新加坡）公司和苏桥生物（苏州）公司，他具有丰富的生物行业相关知识和经验，熟悉原液生产过程中质量体系，合规(包括内外部审计)、供应商质量管理、物料管理、质量控制和验证(包括设备、工艺、分析方法、公用工程和计算机系统验证)，并精通于医学实验室检测。罗仁豪先生从台湾阳明大学医学技术专业获得理学士学位。2012年，他完成了罗氏质量专业认证，进一步提升了专业资历。

Maurice B. Parlane

Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE’s Asia Pacific Regulatory and Quality Harmonization committee and leader of the Process Validation Team and is a member of the Guidance Documents Committee. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016. He is currently serving as the Leader of the ISPE Process Validation Team.

孙永劼

在制药行业工程项目管理和制药设备清洁维护方面拥有10年的丰富经验
擅长设计开发洁净公用工程、核心工艺系统、核心制药工艺设备的清洗、除锈及钝化的技术方案
组织并主编了《制药除锈工艺实施手册》
主导实施了包括Pfizer、Lily、Sanofi、Baxter等跨国公司和Wuxi Biologics、Innovent Biologics等国内头部药企的不锈钢系统腐蚀管理策略制定、红锈腐蚀检测与分析、除锈技术实施等专业技术项目

彭程

彭程毕业于天津大学，化学工程与工艺专业；曾就职于中美史克制药有限公司，诺和诺德（中国）制药有限公司。在所就职的跨国企业内历任质量经理，公用工程经理以及成品部高级经理等职务，负责新产品，新产线的引入，验证及产能提升；成品质量管控；支持国内外各项质量审计，认证。设备全生命周期管理工作等

郭融

拥有超过15年的医疗器械行业经验，曾任职于世界顶级的医药及医疗器械公司，目前为上海新耀湃科医疗科技股份有限公司的研发副总经理。

倪峰

倪峰博士，长期从事创新药物研究和重大医药品种的产业化开发，具有多年海内外科研院所和大型制药企业工作经验。熟悉药品开发、新药创制、生产经营和战略管控等工作。现担任中国医药工业研究总院副总经理，上海市药物合成工程中心主任，曾担任上市公司副总裁、国家口服固体制剂产业链平台负责人，上海医药工业研究院博士生导师和国内多所高校博士研究生导师； 中国生物基材料专委会、上海市药学会药物化学专委会委员； 国家工信部、科技部、教育部、科协等专家库专家；曾获上海市东方英才，国资委优秀创新人才、上海市优秀技术带头人、上海市浦江人才等

Christoph Herwig

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to entering his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. From 2008 to 2023, he was a full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma Austria, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently acts as senior scientific advisor for Körber.

Christoph Herwig，生物过程工程师，毕业于亚琛工业大学（RWTH Aachen），在进入瑞士洛桑联邦理工学院（EPFL）攻读跨学科生物过程识别博士学位之前，曾在工业界从事大型化工设施的设计和调试工作。随后，他将自己的职业定位在生物制药行业的生物过程开发与设施设计之间的交叉领域。从2008年到2023年，他担任维也纳工业大学（Vienna University of Technology）生物化学工程的全职教授，研究领域主要集中在开发生物制药过程中基于过程分析技术（PAT）和质量源于设计（QbD）原则的数据科学方法，以实现集成和高效的生物过程开发。2013年，他创立了Exputec公司，该公司现已成为柯尔柏医药科技奥地利公司的一部分，致力于为生物制药生命周期提供领先的数据科学软件解决方案。目前，Christoph Herwig在柯尔柏担任高级科学顾问。

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. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

刘志勇

从事医药行业25年，包括药品研发、生产运营管理、质量管理和GMP厂房的设计、建设和验证。熟悉生产工艺改进、质量体系建设与运行等，多次主持通过美、欧盟、巴西、哥伦比亚、PIC/S等世界各国/组织针对原料药与制剂的现场检查，包括口服固体制剂、凝胶、无菌注射剂水剂、冻干粉针等剂型。熟悉国内外GMP法规，并有多年实践经验。
先后在多家国内大型企业任职，负责生产和全面的质量管理，目前任上海复宏汉霖生产总经理，负责企业整体生产运营工作。

Martin Schöler

Currently working as Vice President • Technology of Engineering and Design, with responsibility for mechanical and electrical design, software development and documentation. Focus on pharmaceutical processes and GMP, machine safety, leadership and organizational development. Special interest in the field of pharmaceutical containment, scientific collaboration and academic lecturing

王卫兵

王博士从事医药行业30多年，包括药品研发分析，质量管理和生产运营管理。熟悉从实验室管理，到质量体系建设与运行，集团化企业质量管理等，多次主持通过美、欧、日、WHO等世界各国/组织针对原料药与制剂的现场检查，包括原料药（含无菌原料药），口服制剂，注射剂，涵盖人用药及兽药。熟悉国内外法规，并有多年实践经验。2010版药品GMP指南编委。
王博士先后在多家国内大型企业，国际跨国公司任职，担任质量负责人，目前任江苏恩华药业副总裁，负责企业整体生产质量运营工作。

郑磊明

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,
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 Höfliger 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.

李梦龙

史俊

史俊，作为在制药行业拥有超20年经验的数字化与AI领域专家，现任上海舶望制药有限公司IT总监。他在推动企业数字化转型、AI技术应用以及合规性管理方面取得了卓越成就。他曾为阿斯利康、三叶草生物等知名制药公司制定并执行了全球信息化战略，成功支持了公司业务的快速增长。在他职业生涯中曾主导了多个大型数字化项目，包括基于AIDD/CADD平台的建立，大幅提升了研发效率，并通过引入云计算和人工智能技术，推动了公司在行业中的技术领先地位。
在制药行业的合规性管理方面，史俊成功为多家生物制药公司建立了符合GxP法规的计算机化系统管理体系，确保了数据完整性和合规性，并多次通过中国和国际GMP审查。他还领导了跨国团队，成功融合了来自不同文化背景的成员，提升了团队整体绩效，实现了全球化交付。
史俊先生以其前瞻性的技术视野、卓越的领导力和丰富的行业经验，持续推动制药行业的数字化转型与创新。

杨彬

杨彬，现任上海顶岩自动化工程有限公司总经理。他是一位资深的项目经理，拥有超过15年的制药行业质量管理经验。他曾在多家知名企业担任重要职位，包括艾默生过程控制有限公司（制药行业中国区负责人）、美国Dwyer仪器有限公司（中国区负责人）等。杨先生在项目管理方面经验丰富，曾主导多个大型项目，如龙沙广州基地项目、重庆博腾108/110车间自控项目、南京迈瑞MES项目、北京302医院制剂项目、药明康德Phase II项目等，涵盖MES、SAP、WMS、SCADA等多种系统。此外，他还持有PMP证书，是ISPE GAMP成员和E-Works专家组成员，精通英语，并接受过Batch/MES/PI/PLC的专业培训。

王董明

王董明先生任信达生物质量高级副总裁一职，全面负责集团生产质量管理。同时担任全国生化检测标准化技术委员会副秘书长与沈阳药科大学亦弘商学院课程主席。曾先后任职百济神州、罗氏、诺华、阿斯利康，担任中国区质量运营负责人、临床研发QA专家、技术研发QA负责人、亚太区分销领域质量负责人、QC经理、无菌生产经理等职务。参与新产品研发项目质量管理、领导各工厂质量运营，为质量运营团队提供领导力和战略方针以符合全球质量保证和公司业务的目标。在产品研发，生产和供应链质量管理领域有20 余年的跨国公司从业经验，并参与2010与2022版本GMP无菌指南的编写与审稿工作。

郑磊明

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,
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 Höfliger 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.

王卫兵

王博士从事医药行业30多年，包括药品研发分析，质量管理和生产运营管理。熟悉从实验室管理，到质量体系建设与运行，集团化企业质量管理等，多次主持通过美、欧、日、WHO等世界各国/组织针对原料药与制剂的现场检查，包括原料药（含无菌原料药），口服制剂，注射剂，涵盖人用药及兽药。熟悉国内外法规，并有多年实践经验。2010版药品GMP指南编委。
王博士先后在多家国内大型企业，国际跨国公司任职，担任质量负责人，目前任江苏恩华药业副总裁，负责企业整体生产质量运营工作。

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

朱荟琳

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

顾晨

2008年毕业于澳大利亚university of Wollongong电气工程与信息工程专业，工程学硕士
2011年-2017年星德科包装技术（2020年更名，原博世包装技术），技术销售
2017年至今星德科包装技术，液体制剂设备高级产品经理

Norman Goldschmidt

Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) Author/Expert, Adjunct Professor at the New Jersey Institute of Technology, Lead/Contributing Author on 8 ISPE Guides well as author, contributor and instructor for ISPE, ASHRAE, NSF, FDA, HCA, TGA and others.

刘苏建

在无菌药品制造领域拥有20年从业经验，现任礼来苏州制药有限公司无菌保证部高级资深工程师。专业领域涵盖无菌生产工艺、无菌更衣管理、环境监测、无菌人员培训及培养基模拟灌装操作。曾多次参与企业的内部及外部GMP审计工作，并于2021年参与国家药品GMP指南的编写工作，致力于提升无菌制药行业的质量标准与合规水平。

于大鹏

于大鹏先生在药包材行业拥有16年以上的工作经验, 具有丰富的药包材相关知识和经验，熟悉生物制品及化药的上市流程，并精通于注射笔产品相关法规与市场推广。

王胜

王胜，中山大学药理学硕士，工程师，从事制药行业20年。熟悉实验室管理，质量体系建设与运行，具有丰富的实践经验，多次主导质量体系搭建，多次主持通过中、欧、澳等世界各国的GMP现场检查，包括口服固体制剂，注射剂等。熟悉国内外法规，多次参与药监局、技术协会牵头的法规指南、行业标准起草修订工作，药品生产质量管理规范无菌附录修订成员。
王胜先后在多家国内大型企业，国际跨国公司任职，目前任广州百济神州生物制药有限公司质量负责人，负责企业质量管理运营工作。

任民

从事医药行业30多年，先后在罗氏维生素、惠氏营养品、美国药典中华区、雅培眼力键、百特上海、美敦力中国、百济上海、长春金赛等国内外医药企业中从事质量控制，质量保证和地产化项目工作。目前任职于成都康诺行，负责运营管理工作。
在2009-2010年期间，参与编写2010版 GMP指南中质量管理体系和原料药部分；2015-2017年参与中国药典通则项目--隔离器，制药用水，质量量度等；2018-2020年参与国内生物药MAH和医疗器械MAH首个试点项目；2021年参与单抗检查指南的编写； 2021-2023年期间，参与编写GMP指南再版中无菌药品和计算机化系统验证部分。参与了多次NMPA，FDA等国内外GMP检查，以及多次NMPA药品和器械海外检查活动。

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

喻咏梅

现任阿克索信息董事长。
拥有30年制药行业质量管理经验，数十次全球药政官方检查顺利通过。
拥有重庆药检所，葛兰素史克，复星凯林制药和博腾制药多年工作经验，涉及原料药、气雾剂，OSD，软膏和无菌产品等领域， 负责质量QA/QC，注册、数据创新，CSV以及HR等，多项数字化实践成为制药行业数字化转型标杆。 
拥有中国药科大学药物分析学士，重庆大学管理硕士和中欧商学院EMBA学位。