Bin Ni

毕业于同济大学，现任中国电子系统工程第四建设有限公司生物医药事业部总经理、昆山协多利洁净系统股份有限公司董事
在医药行业工程领域拥有近20年丰富项目实施管理经验，曾负责阿斯利康、迈瑞医疗、和记黄埔、赛默飞世尔等众多行业内重点生物医药项目建设实施，专注为客户提供全过程工程服务

孙健

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.

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。

王燕红

复旦研究生毕业后从事生命科学行业20 +年的合规GMP项目工作经验。深耕生命科学行业设计实施和项目良好实践，并根据监管要求和 GAMP 指南提供具体和完整的GMP和数字化解决方案和实施方案。参与众多数字化系统项目实施包括 SCADA 系统, PCS 系统, WMS 系统, LIMS 系统, ERP 系统, BMS/EMS 系统, DMS 系统, QMS 系统, XHQ 系统等。
中国国际制药机械展览会合规GMP讲师，国家药品监督管理局核查中心数字化讲师，中国研究院研究班数字化合规讲师。
GAMP® 5 (2nd Edition)中文版翻译项目经理； GAMP 课程，DI课程和 Annex11/Part1课程1认证讲师和培训师；技术支持并编制 ISPE总部GAMP培训教材和资料；技术支持和参与GAMP South Asia技术和法规更新讨论；参加ISPE新加坡成立25th 周年年会并推动亚太数字化和AI交流。
西门子公司内部和外部合规GMP和GAMP负责人，

张睿

2006年加入诺和诺德，持有软件工程硕士学位及工商管理硕士 (MBA) 学位.
20+年跨国制药企业制造信息化、运营技术 (OT) 与自动化领域工作经验，专长涵盖/ IT/OT技术架构, 计算机化系统验证 (CSV), 制造执行系统 (MES) 实施, IT合规与安全体系构建, 智能制造解决方案设计, 商业化生产IT/OT运营管理； 15+年跨国药企制造IT/OT与自动化项目管理及领导经验，精通 PMP方法论, GAMP5, GMP环境下的敏捷软件开发（SAFe框架）与DevOps实践
GMP环境下主导完成软件开发生命周期（开发/测试/验证/发布）、系统集成及IT/OT系统部署项目，包括多条新产线引进项目, 制药厂房设施项目, 自动化仓储系统实施, 工业4.0试点项目（制造智能平台建设）
制药计算机系统质量合规管理专家，深度掌握 GxP法规体系, FDA 21 CFR Part 11电子记录规范, COBIT（信息及相关技术控制目标）框架,及IT安全
作为制药制造领域专家，推动企业数字化转型与智能制造/工业4.0倡议落地。担任Pharma MES组织成员及特邀讲师，MESA国际智能制造联盟成员，亦宏商学院客座教授

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

作为STERIS公司的高级技术服务经理，Richard一直致力于为客户提供洁净室污染控制、工艺设备清洗以及无菌保证与维护方面的技术支持和培训。他经常在ISPE和PDA等行业活动中发表演讲，并且是ISPE“清洁验证原则培训课程”的认证培训师。Richard在制药行业的生产、验证、咨询和技术支持方面拥有超过25年的经验。

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.

唐孝波

2009年，进入中国药科大学药物化学研究生学习，研究方向为新型抗肿瘤耐性药物的研究，发表多篇SCI论文；
2012年，在中国科学院上海药物研究所从事新药研究，研究方向为基于蛋白质结构的药物分子设计、合成和药理活性评价；
2013年至今，在上海市药品监管系统长期从事药品生产、流通、使用监管和稽查工作，目前在上海市药品监督管理局药品监管处工作，具体承担上海市疫苗、血液制品、CGT产品等生物制品和化学原料药的监管；牵头制定规范性文件《上海市药品生产经营企业质量安全重点管理人员管理办法》，修订《上海市自体嵌合抗原受体T细胞（CAR-T）监督管理规定》，推进地方标准《药品生产全过程数字化追溯体系建设和运行规范》的实施，参加与其配套的系列团体标准的制定；具体经办本市生物制品分段生产试点工作。

于建进

于建进，1987 年毕业于上海工业大学，持有注册安全工程师、环保工程师、高级保卫师专业资质。现受聘担任上海市节能环保服务业协会、上海生物医药前沿产业创新中心顾问，同时为中国医药企业管理协会 EHS 管理专业委员会首批特聘专家，上海市一、二、三级保卫管理员考官。
从业期间，曾先后任职于罗氏、帝斯曼、索玛格等知名企业，长期专职负责 EHS 全体系管理工作。2009 年入职上海医药（集团）有限公司，先后在集团技术质量部、安全保卫部履职，全面统筹集团安全生产、生态环保、能源管控及治安保卫等相关管理工作，连续十六年参与上海医药ESG/社会责任报告的编制工作。

林满阳

林满阳先生，正高级工程师，信达生物制药工程运营高级首席工程师。有20多年的国际标准生物制药工程项目全生命周期管理经验。 有丰富的生物制药工厂GMP运行管理经验，有丰富的接受GMP认证和国际客户审计经验。熟悉国际制药标准、规范和指南；熟悉国际生物制药工程发展趋势和最新实践。发表10余篇专业论文，并作为专家在ISPE、国药工程、弗戈、易贸、制药制造等大会论坛分享生物制药项目管理、运行经验。

王璐

王夏欢子

王夏欢子，国药工程数智化事业部主管、自动化高级工程师、智能制造工程师、PMP认证项目经理。拥有17年医药精细化工领域数智化项目设计与管理经验，作为专业负责人主导百余项自动化、信息化系统建设项目，服务客户包括辉瑞、恒瑞、费森尤斯卡比、信达、华润博雅、莱士等国内外知名药企。深度参与国药集团智能工厂梯度培育与评价体系构建工作，具备从项目设计、落地到行业标准建设的全链条实践经验。

丁丰俐

丁丰俐，医药数字化战略专家。拥有30年以上企业信息化、数字化项目经验，25年医药行业全链条数字化实战经验，主导了大型医药集团十二五、十三五、十四五数字化战略规划的制定，并推动战略落地实施。深度参与并成功交付了30+项大型医药数字化项目，覆盖医药研发、智能工厂设计、制药生产管理、质量管理（GxP）、运营管理（ERP）、流通追溯监管等领域。在医药智能制造领域，参与或主导了三家医药上市公司智能制造规划的顶层设计，同时积极探索人工智能与制药业务的融合创新，探索人工智能在药品研发及制药工艺优化方面的应用路径。

郭融

郭融，毕业于郑州大学药理学专业，并获得硕士学位。曾在全球顶级的医药及医疗器械公司担任职务超过10年，作为上海新耀湃科医疗科技股份有限公司联合创始人，担任研发副总裁，全面负责公司产品管线的研发。主导建立了4大产品平台，包括药物注射系统、药物无菌转移系统、自我注射系统及家庭美容，推出了一系列具有自主知识产权的创新产品，已授权专利60余项，其中有12项发明专利。

Stephan Rennecke

斯特凡・雷内克博士拥有德国克劳斯塔尔工业大学固体过程工程专业博士学位。他在过程工业、装备研发及制造数字化领域拥有丰富经验，此前还曾在化妆品行业任职。
自 2024 年加入菲特（Fette Compacting）以来，雷内克博士一直领导未来技术部，负责制药生产领域的技术调研与新技术战略预研工作。他专注于发掘前沿技术趋势，并将其转化为面向未来的口服固体制剂生产解决方案。
2026 年起，雷内克博士同时担任菲特人工智能中心（AI Hub）负责人，与团队共同开发全新的数字化及人工智能解决方案，重点聚焦智能辅助系统、数据驱动型工艺支持，以及面向未来的自动化生产理念。
他目前的研究融合了过程工程、制药生产技术与数字化创新，致力于开发更智能、更灵活、更高效的制药生产解决方案。

孙易木

孙易木，拥有二十年行业IT开发、组织管理、数字化转型和十年以上的药企GMP IT管理经验，包括CSV和自控运维。
曾任职于陶氏化学、药明康德、药明奥测和嘉和生物。同济大学信息管理和信息系统学士，同济大学管理信息系统硕士。

陈旖

陈旖女士，现任礼来苏州制药有限公司技术服务和制造科学部首席无菌保证工程师，负责公司环境监测、无菌模拟灌装策略的制定与实施等无菌保证工作。拥有10余年制药行业经验，在环境监测管理、洁净公用系统验证和无菌保证领域具备丰富经验。多次参与省局、国家局及欧盟PAI/GMP审计，并参与审计回复和决策。多次受邀作为讲者参与注射剂工业大会和中国制药工程大会会议报告和北大IPEM无菌保证系列课程授课。拥有美国普度大学食品科学硕士学位。

王斌

王斌先生作为默克Merck客户技术应用总监，带领了一支高度全球化的团队，该团队包括技术应用专家，区域市场专员，细分行业市场专家，市场宣传与沟通和产品经理。该团队致力于为生物制药公司提供全面的产品和应用解决方案，涵盖从上游到下游全面的产品和技术应用。在此职位前，王斌曾担任中国科学与技术解决方案团队，亚洲工艺工程师团队和大中华区工艺开发团队负责人，并曾在美国总部MSAT团队任职，支持北美生物制药公司的工艺开发与放大工作。王斌先生在中国和美国的生物制药行业拥有21年工作经验，曾经在复星生物，亚洲联合抗体，百时美施贵宝（BMS）等公司负责工艺开发和GMP符合等职位。他是华东理工大学分离课程的客座讲师，曾经在北京大学IPEM项目、NMPA高级研修院等担任客座讲师。
王斌先生获得新加坡劳动力发展部（WDA）资格认定的培训师曾负责亚洲重要客户的培训工作。王斌曾经在中国、美国和墨西哥等多个国际学术会议上作为演讲人，会议主席和小组讨论主持人，包括ACS/IBC/BIT/DCVMN/VacChina/WVC/Affinity等组织的会议。

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.

周志仁

周志仁毕业于同济大学，获得暖通空调节能方向硕士学位。具有超过17年的可持续低碳咨询经验，包括高能耗企业能效优化诊断、碳减排路径规划、能源管理数字化规划、节能管理培训、零碳工厂和园区咨询等。在既有工厂和新建工厂可持续发展（节能低碳）咨询都有丰富的经验。
周志仁尤其在制药行业的经验较多，在药企能效提升方面的经验不仅包括公辅设备的节能，同时在工艺生产节能也具有较多的积累。

许建辰

许建辰博士，现任诺和诺德，质量合规副总监，负责对中国法规合规提供建议和方案，并为检查准备和现场提供技术支持。
曾在诺和诺德天津生产厂和欧洲生产厂担任过多个质量管理和专家岗位。在生物制品生产GMP管理，无菌生产环境监控，质量保证，质量体系等领域有十余年的丰富实践经验。熟悉欧洲和中国的法规体系，行业立场及实践趋势。
中国药科大学化学制药学士，天津大学应用化学博士。

陈小彬

陈小彬现任浙江海正药业股份有限公司验证总监。他拥有沈阳药科大学药物制剂专业学士学位及北京大学国际药物工程管理（IPEM）硕士学位。他在医药行业从业超过20年，在项目管理和监管审计方面拥有丰富经验。他专注于将风险管理模型与统计方法融入质量管理，破解实操难题，实现产品质量风险的精准管控。他曾参与2023年版《药品GMP指南：原料药》的编写工作。

张睿

2006年加入诺和诺德，持有软件工程硕士学位及工商管理硕士 (MBA) 学位.
20+年跨国制药企业制造信息化、运营技术 (OT) 与自动化领域工作经验，专长涵盖/ IT/OT技术架构, 计算机化系统验证 (CSV), 制造执行系统 (MES) 实施, IT合规与安全体系构建, 智能制造解决方案设计, 商业化生产IT/OT运营管理； 15+年跨国药企制造IT/OT与自动化项目管理及领导经验，精通 PMP方法论, GAMP5, GMP环境下的敏捷软件开发（SAFe框架）与DevOps实践
GMP环境下主导完成软件开发生命周期（开发/测试/验证/发布）、系统集成及IT/OT系统部署项目，包括多条新产线引进项目, 制药厂房设施项目, 自动化仓储系统实施, 工业4.0试点项目（制造智能平台建设）
制药计算机系统质量合规管理专家，深度掌握 GxP法规体系, FDA 21 CFR Part 11电子记录规范, COBIT（信息及相关技术控制目标）框架,及IT安全
作为制药制造领域专家，推动企业数字化转型与智能制造/工业4.0倡议落地。担任Pharma MES组织成员及特邀讲师，MESA国际智能制造联盟成员，亦宏商学院客座教授

李达龙

李达龙，就职于扬子江药业集团，担任集团有限工厂技术负责人，负责产品的技术转移、工艺验证、清洁验证、设备确认、上市后产品工艺改进和注册备案工作。拥有25年的化学药生产质量技术管理经验，专注于产品生产技术运用和精益改进；先后设计并组建了3个独立冻干粉针剂生产线，并负责相应的独立运营超过10年；曾参与了工厂首个注射剂的欧盟项目、冻干粉针剂FDA项目的全过程。

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。

王燕红

复旦研究生毕业后从事生命科学行业20 +年的合规GMP项目工作经验。深耕生命科学行业设计实施和项目良好实践，并根据监管要求和 GAMP 指南提供具体和完整的GMP和数字化解决方案和实施方案。参与众多数字化系统项目实施包括 SCADA 系统, PCS 系统, WMS 系统, LIMS 系统, ERP 系统, BMS/EMS 系统, DMS 系统, QMS 系统, XHQ 系统等。
中国国际制药机械展览会合规GMP讲师，国家药品监督管理局核查中心数字化讲师，中国研究院研究班数字化合规讲师。
GAMP® 5 (2nd Edition)中文版翻译项目经理； GAMP 课程，DI课程和 Annex11/Part1课程1认证讲师和培训师；技术支持并编制 ISPE总部GAMP培训教材和资料；技术支持和参与GAMP South Asia技术和法规更新讨论；参加ISPE新加坡成立25th 周年年会并推动亚太数字化和AI交流。
西门子公司内部和外部合规GMP和GAMP负责人，

孙健

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.

高晓伟

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。

朱荟琳

药明生物临床生产负责人（Head of Clinical Manufacturing），拥有15年生物制药行业经验。
负责管理覆盖多个生产基地的临床生产网络，包含多个细胞库及原液（DS）GMP生产基地，提供符合国际化质量标准的原液产品的生产。
在细胞培养工艺开发、原液工艺技术转移与放大、中试生产、GMP生产及质量管理等方面具有深厚的专业经验。
多年端到端生物制药产品CMC全生命周期管理经验，涵盖的技术路线包括单抗（mAb）、双特异抗体（bsAb）及抗体偶联药物（ADC）。
自2022年起担任ISPE中国生物制药分委员会核心成员，主导并参与多项ISPE活动的策划与执行，包括ISPE中国年会以及线上与线下分委员会活动。

刘珊珊

刘珊珊现任 No deviation 技术总监，负责公司的技术与创新发展战略，同时推动员工的专业成长。她也是公司核心团队成员之一，参与制定公司的国际化发展和业务战略。
她拥有 英国伯明翰大学生化工程硕士学位，并在全球制药行业积累了 18 年经验，曾在知名咨询公司和制药巨头 诺华任职，专注于工艺、质量、合规及法规事务。
刘珊珊热衷于连接生命科学领域的人才与技术，致力于推动国际合作。目前，她担任 ISPE 国际理事会（International Board） 成员，为其全球使命和愿景贡献力量。

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

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 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.

杜婧

顾晨

顾晨，拥有电气工程与计算机工程硕士学位，2011 年加入星德科（原博世包装技术），拥有十余年无菌生产设备项目经验。目前主要负责复杂工艺流程解决方案、技术引进及市场推广工作。

张可

张可先生现任罗克韦尔自动化生命科学行业高级顾问，在工业信息化及数字化解决方案领域拥有逾 20 年的深厚积淀。自加入罗克韦尔 15 年来，他深耕制药行业 MES 系统的设计与实施，对固体制剂、无菌制剂及生物疫苗等领域的生产工艺有着深刻理解。他曾深度参与国内大型疫苗企业的数字化转型项目，擅长从工艺底层需求出发，构建生产的数字化蓝图。目前，张可致力于将信息化技术、混合建模技术与传统自动化深度融合，助力药企在合规前提下实现工艺优化与卓越制造。

陈雅萍

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。

岳迪

岳迪，华中科技大学硕士、MBA，现任testo德图仪器大中华区医药事业部总监。她拥有15年以上制药行业从业经验，曾任职于Austar奥星、国药工程等行业知名企业，积累了丰富的制药及生物领域相关实战经验，深耕行业多年，助力企业实现医药领域业务拓展与合规运营。凭借出色的领导力与强烈的责任感，她成功制定并落地医药事业部的战略目标，带领团队实现突破性发展，进一步扩大了公司在大中华区医药市场的销售规模与行业影响力。

凌刚

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.

胡晓蕾

胡晓蕾女士是德勤中国的税务合伙人，拥有超过20年的专业服务经验。胡女士被《国际税收》连续多年收录为杰出税务顾问和杰出女性税务领导，她目前担任江苏省注册税务师协会常务理事以及上海美国商会南京中心副主席。 胡晓蕾女士的专业经验包括为企业集团和大型企业提供整体税务合规和税负优化方案，在企业并购中提供税务架构规划、税务尽职调查、股权和经营结构税务规划。她自2005年开始已为多家境内外公司提供上市税务服务。 胡女士所领导的德勤南京税务团队是“四大”之中在宁历史最久、规模最大的团队，目前是苏皖地区四大中唯一的5A等级税务师事务所。 胡晓蕾女士毕业于南京大学法学院，是中国注册会计师与注册税务师。

宋晓晖

宋晓晖，生物医药咨询与规划专家，美国注册电气工程师，国际制药项目管理协会中国区制药工程技术专家委员会副主任，中国医药教育协会制药技术专委会常务委员，中国生化制药工业协会重组药物分会理事会理事。天俱时集团副董事长、科技委员会副主席。
燕山大学学士，The University of Toledo美国托莱多大学硕士，北京大学硕士，中欧国际工商学院DBA。曾服务于SSOE Group、中信戴卡股份有限公司以及香港奥星集团等企业。专注于抗体、疫苗、生物制剂、固体制剂、无菌制剂等领域。擅长产业战略规划与设计、产品管线布局与趋势研判,并具备从工艺开发与技术成果转化,到概念设计及工程落地,直至实现商业化生产转化的完整执行经验。主导过广州百济神州ADC&DS4车间项目、百济神州上海创新中心项目、高校生物医药技术转移转化中心项目、Henkel绿色高端胶粘剂产业化基地项目、绿叶嘉奥CNS重组及药物研发生产基地项目、广州诺诚健华抗癌药生产基地建设项目等多个大型项目。

秘宁

秘宁， 毕业于南开大学物理化学专业, 获得硕士学位。毕业后, 先后任职无锡药明，保诺医药及百济神州，从事新药研发及供应链管理工作。2020年12月， 加入迪哲医药担任临床供应链负责人。凭借十年供应链经验和出色的领导力， 构建临床供应团队， 带领团队紧跟公司开展战略， 负责临床用药需要计划并管理多个全球多中心临床项目和国内临床项目的供药工作，以合规高效的方式助力公司开发目标达成。

李梦龙

毛磊

毛磊，先后毕业于北京邮电大学，中国科学院大学，获得硕士学位。现任乐普生物IT部负责人，推动乐普生物在临床前研发、临床研究、CMC、质量管理、营销和销售管理、供应链管理、人力资源管理等领域，逐步实现信息化、数字化和AI智能化，创造了合规、高效和智能的效益。他曾先后任中国普天（中央企业、曾经的电子百强第一名）、蓝色光标（中国最大的数字营销集团）IT负责人，拥有丰富的跨行业、集团企业的信息化、数字化经验。

汪毅

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

陈一飞

陈一飞博士，上海药品审评核查中心 创新与监管科学发展部 部长。

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.

孙晓丹

孙晓丹女士拥有20 余年医疗投资管理与创业经验，深耕医疗产业投资、战略布局及企业运营全链条领域。职业生涯早期，她先后任职于威高集团（HK1066）、柏盛集团（002382）战略部，具备丰富的跨国医疗产业合作与资源整合经验。作为歌路资本创始人，专注医疗领域投行及投资，聚焦创新药、医疗器械等高成长性赛道，迄今已助力上百家优质医疗创新企业完成融资落地，为产业资本与优质项目搭建高效对接桥梁。孙晓丹女士核心擅长医疗资源整合、国际化合作及投资者关系管理，长期深耕医疗产业生态，致力于为创新药与医疗器械企业提供专业资本服务，助力企业快速成长与规模化发展。

王炳刚

王炳刚，中国药科大学制药工程硕士，先后任职于欧美跨国药企、国内生物药龙头企业，现任长春金赛药业验证副总监，负责原液及制剂工艺验证管理。专注生物药清洁验证领域多年，精通清洁验证全生命周期管理与合规落地。多次参与 FDA、欧盟、中国 GMP 相关的内外部审计及现场核查，在生物药清洁验证实践方面拥有丰富实战经验。

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.

史岚

史岚 ，现任上海市药品监督管理局药品监管处处长，曾在政策法规和稽查部门工作。主要研究领域包括药品监管政策、药品上市许可持有人监管、药品数字化追溯、药品现代物流标准、药品信用分级监管等方面。曾获得全国食品药品监管系统法制宣传教育工作先进个人、首届“全国卫生法制理论研讨会”论文一等奖，为国家药品监督管理局高级研修学院特聘专家。

倪坚宏

倪坚宏，上海勃林格殷格翰药业有限公司（退休）首席工程师；ISPE会员。在制药行业从业近40年。有近28年外资知名药企的工程、设备管理经验。对一线的设备维修、管理、选型以及不同系统、不同工况的材料选用有着丰富的实操经验，同时对新建的工程项目也有着丰富的施工质量的经验积累。曾参与并主导多个项目的新建、验证工作，熟悉GMP’s对于制药企业设备设施的要求。负责改扩建项目从URS（ROOM BOOK）的全过程。同时，对于验证和运维中的重点、难点有着丰富的知识积累。在多年的项目交付和系统（设备）优化、改进工作中，无一次延期，以近乎零缺陷的结果顺利交付生产。同时协助企业在在节能减排活动中，于2021年荣获中国制药行业第一家碳中和工厂的荣誉。
同时，曾为吉林省药品查验中心人员及多家内外资制药企业进行内部培训，并与国内多家知名培训机构合作，进行授课培训 .

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。

严旭

- 北京大学医学部药学院化学学士，获中欧国际工商管理学院在职MAB课程毕业证书。
- 拥有外企制药30+年质量管理经验。熟悉GMP、GSP相关法规。致力于质量法规倡导。
- 历任诺华中国工厂质量负责人，生产业务负责人。外派新加坡及美国工厂工作3年
- 葛兰素史克中国区3家处方药工厂丰富的质量管理经验，包括建立和管理中国商业质量部门，质量体系建立实施，质量审计和管理，熟悉中国质量法规合规要求和持有人制度。
- 2019年-2024年连任两届RDPAC质量组主席，推动行业与监管，学术界进行质量法规交流倡导，分享国际实践，宣传中国法规要求，确保持续质量合规。
- RDPAC高级兼职顾问， ISPE中国合规分委会副主席（2024-2025年）

何国玲

何国玲女士，前后分别就读于南开大学化学系，获得学士学位；天津大学管理科学与工程系，获硕士学位。在赛诺菲工作近30年，曾任杭州赛诺菲民生健康药业厂长、赛诺菲北京工厂厂长，赛诺菲（中国）制造与供应负责人，等职。现任赛诺菲InsuLINK IFB项目高级顾问，负责领导胰岛素设施项目的战略举措。凭借其在医药制造与供应战略管理、项目开发和制造运营方面的丰富专业知识，何女士在管理复杂的多利益相关者的转型项目中积累了宝贵的实践洞察力。她的工作聚焦中国及亚太市场构建韧性、高效且合规的制造供应网络。何女士还致力于运用数字化创新和战略合作伙伴关系来应对行业挑战，推动运营卓越。

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.

张睿

2006年加入诺和诺德，持有软件工程硕士学位及工商管理硕士 (MBA) 学位.
20+年跨国制药企业制造信息化、运营技术 (OT) 与自动化领域工作经验，专长涵盖/ IT/OT技术架构, 计算机化系统验证 (CSV), 制造执行系统 (MES) 实施, IT合规与安全体系构建, 智能制造解决方案设计, 商业化生产IT/OT运营管理； 15+年跨国药企制造IT/OT与自动化项目管理及领导经验，精通 PMP方法论, GAMP5, GMP环境下的敏捷软件开发（SAFe框架）与DevOps实践
GMP环境下主导完成软件开发生命周期（开发/测试/验证/发布）、系统集成及IT/OT系统部署项目，包括多条新产线引进项目, 制药厂房设施项目, 自动化仓储系统实施, 工业4.0试点项目（制造智能平台建设）
制药计算机系统质量合规管理专家，深度掌握 GxP法规体系, FDA 21 CFR Part 11电子记录规范, COBIT（信息及相关技术控制目标）框架,及IT安全
作为制药制造领域专家，推动企业数字化转型与智能制造/工业4.0倡议落地。担任Pharma MES组织成员及特邀讲师，MESA国际智能制造联盟成员，亦宏商学院客座教授

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.

孙小峰

孙小峰，河海大学机械工程硕士，高级工程师。现任山东威高普瑞医药包装有限公司副总经理，同时兼任注射笔公司总经理，负责公司在预灌封注射器及给药装置领域的研发战略制定与产业化推进。他在药品包装及医疗器械行业拥有十余年经验，长期专注于药械组合产品的研发与工程化转化，具备从产品定义、设计开发到量产导入的全生命周期管理经验。在技术领域，他主导了自动注射笔精密传动、多剂量给药控制等关键技术的研发与产业化，拥有多项国内外发明专利（包括一种自动注射笔、可调剂量注射笔相关核心专利），主导起草ISO 11608-5在国内的标准转化。在研发管理与产业化方面，他推动建立了面向工程化确定性的研发体系，促进预灌封注射器与注射笔产品的平台化开发及规模化制造，支撑公司在中国药品包装及给药系统领域保持领先地位。自兼任注射笔子公司总经理以来，他进一步推动研发与制造的深度融合，实现了高端给药装置从概念设计到商业化落地的系统性能力建设。

徐方敏

徐方敏，本科毕业于哈尔滨工业大学环境科学专业，中国人民大学硕士学历，现任博纳销售市场副总经理、KVS业务负责人。深耕暖通行业19年，主管市场运营与大型净化暖通项目落地，主导生物医药、医疗实验室等重点工程建设，持有暖通设备相关专利。曾牵头火神山医院净化空调保障工作，深耕洁净空调节能技术研究，是制药与医疗暖通领域资深专业人才，行业实操与技术影响力突出。

崔胜良

崔胜良先生，本科毕业于兰州大学化学系，获有机化学学士学位；研究生毕业于清华大学化工系，获生物化工硕士学位。现供职于诺华中国，负责诺华大中华区供应链计划、仓储物流、进出口等工作。崔胜良先生有着20余年跨国制药企业生产运营，财务管理，采购及供应链管理从业经验。

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).

叶健

叶健，毕业于中国药科大学药学专业，现任上海莱士血液制品股份有限公司设备部高级经理兼产能扩建项目部经理，主导公司日常运维、各生产基地设备管理赋能及新建35米高层、7万多平方米的产能扩建项目建设。他在生物制品领域拥有超20年经验，职业路径始于上海莱士生产管理，后任职国内知名制药装备企业，2021年重返上海莱士。精通上下游工艺设计、水针线/冻干线/BFS/PFS等无菌制剂车间设计及设备全生命周期管理，持有PMP证书。兼具甲方生产运营与乙方设计制造双重视角，通过严格的项目管理实践和系统化培训赋能，推动建立覆盖设备全生命周期的数字化管理体系，显著提升团队专业能力与生产运营效率。

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

作为STERIS公司的高级技术服务经理，Richard一直致力于为客户提供洁净室污染控制、工艺设备清洗以及无菌保证与维护方面的技术支持和培训。他经常在ISPE和PDA等行业活动中发表演讲，并且是ISPE“清洁验证原则培训课程”的认证培训师。Richard在制药行业的生产、验证、咨询和技术支持方面拥有超过25年的经验。

郭劲涛

华兰疫苗IT总监

虞霞

虞霞，本科毕业于北京航空航天大学工业外贸&航空技术专业，并获得上海对外经贸大学国际贸易硕士学位。深耕制药行业二十余年，曾服务于美国APL Logistics, 以及Grunenthal, GlaxoSmithKline, Ipsen等多家欧洲制药企业，职能贯穿端对端供应链，包括需求计划、生产供应、包装与追溯码、仓储与配送管理等，历任中国供应链总监，东南亚区域供应计划总监等，覆盖护肤品、OTC，普药，特药与疫苗等广泛产品范围。

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.

方骅

方骅，毕业于华东理工大学制药工程专业，本科学士学位。目前，他在康希诺生物股份公司担任工程服务中心负责人，主要负责公司固定资产建设项目规划及实施管理。具有25年医药厂房工程项目管理经验，对整个工程项目生命周期，从立项，设计，采购，施工，验证至交付有深入的理解。成功交付多种制药工艺车间及产业园区规划，包含生物制药，无菌灌装，研发大楼，固体制剂，原料药等。 在其职业生涯中，他曾在中石化上海工程有限公司、罗氏制药，上海医药集团等多家行业领先的企业担任技术，项目管理等高级管理职务。自2021年9月起，他开始在康希诺生物股份公司，带领团队交付了约12万方生产厂房及研发中心等建筑。

严旭

- 北京大学医学部药学院化学学士，获中欧国际工商管理学院在职MAB课程毕业证书。
- 拥有外企制药30+年质量管理经验。熟悉GMP、GSP相关法规。致力于质量法规倡导。
- 历任诺华中国工厂质量负责人，生产业务负责人。外派新加坡及美国工厂工作3年
- 葛兰素史克中国区3家处方药工厂丰富的质量管理经验，包括建立和管理中国商业质量部门，质量体系建立实施，质量审计和管理，熟悉中国质量法规合规要求和持有人制度。
- 2019年-2024年连任两届RDPAC质量组主席，推动行业与监管，学术界进行质量法规交流倡导，分享国际实践，宣传中国法规要求，确保持续质量合规。
- RDPAC高级兼职顾问， ISPE中国合规分委会副主席（2024-2025年）

徐舒婷

王晖

拥有近30年跨行业国际经验，曾在亚太、欧洲和中东担任技术、市场及管理岗位。现负责西门子gPROMS产品线在大中华区的业务发展与生态合作，长期推动 gPROMS 在生命科学领域的应用落地，重点覆盖工艺数字孪生、工艺放大、技术转移和生产优化

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是受过专业训练的商业数学家，担任生命科学领域组织的顾问。他拥有十多年专注于技术、创新和转型的经验，致力于推动生命科学领域的进步与卓越，同时协助维护合规性并提升质量水平。他担任GAMP全球软件自动化与人工智能特别兴趣小组秘书，并共同领导了《ISPE GAMP人工智能指南》倡议 – 是该指南的第一联合作者之一。

Julia Schmitz

Julia Schmitz是柯尔柏医药软件有限公司的全球软件集成总监，同时负责领导人工智能开发团队。她致力于推动面向制药行业的符合GxP规范的云端人工智能产品的战略与运营发展。凭借在软件工程及受监管的制药环境方面的深厚背景，她专注于为全球主要制药和生物技术公司提升安全且创新的人工智能能力，同时协调整个组织内的团队、流程和质量标准。

赵阳

在生物制药领域近15年经验，先后在国际国内领先药企公司（Lilly、GenSci、TopAlliance等）从事技术转移、项目管理、市场拓展等工作。与国内国际头部服务公司及供应商保持密切合作关系，尤其在这十几年间落地多个生物实验室、完成2个中试车间建设及2个产业化车间的设计建设。在行业内大型会议中分享技术成果、在行业活动中制定并发行行业标准。在生物医药研发、技术引进和转移、洁净厂房工艺设计以及项目管理等方面经验丰富。

汤自然

2011年加入药明生物，深耕细胞培养工艺开发领域17年，长期致力于生物制药上游工艺的开发与放大研究。在早期至商业化阶段项目中积累了丰富经验，尤其在灌流培养及补料分批培养体系方面具备深厚的技术积累。曾主导多项GMP生产数字化与自动化转型项目，目前负责MFG17基于一次性技术的全自动端到端连续化生物制药生产平台的建设与实施。

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).

刘珊珊

刘珊珊现任 No deviation 技术总监，负责公司的技术与创新发展战略，同时推动员工的专业成长。她也是公司核心团队成员之一，参与制定公司的国际化发展和业务战略。
她拥有 英国伯明翰大学生化工程硕士学位，并在全球制药行业积累了 18 年经验，曾在知名咨询公司和制药巨头 诺华任职，专注于工艺、质量、合规及法规事务。
刘珊珊热衷于连接生命科学领域的人才与技术，致力于推动国际合作。目前，她担任 ISPE 国际理事会（International Board） 成员，为其全球使命和愿景贡献力量。

张睿

2006年加入诺和诺德，持有软件工程硕士学位及工商管理硕士 (MBA) 学位.
20+年跨国制药企业制造信息化、运营技术 (OT) 与自动化领域工作经验，专长涵盖/ IT/OT技术架构, 计算机化系统验证 (CSV), 制造执行系统 (MES) 实施, IT合规与安全体系构建, 智能制造解决方案设计, 商业化生产IT/OT运营管理； 15+年跨国药企制造IT/OT与自动化项目管理及领导经验，精通 PMP方法论, GAMP5, GMP环境下的敏捷软件开发（SAFe框架）与DevOps实践
GMP环境下主导完成软件开发生命周期（开发/测试/验证/发布）、系统集成及IT/OT系统部署项目，包括多条新产线引进项目, 制药厂房设施项目, 自动化仓储系统实施, 工业4.0试点项目（制造智能平台建设）
制药计算机系统质量合规管理专家，深度掌握 GxP法规体系, FDA 21 CFR Part 11电子记录规范, COBIT（信息及相关技术控制目标）框架,及IT安全
作为制药制造领域专家，推动企业数字化转型与智能制造/工业4.0倡议落地。担任Pharma MES组织成员及特邀讲师，MESA国际智能制造联盟成员，亦宏商学院客座教授

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 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.

朱荟琳

药明生物临床生产负责人（Head of Clinical Manufacturing），拥有15年生物制药行业经验。
负责管理覆盖多个生产基地的临床生产网络，包含多个细胞库及原液（DS）GMP生产基地，提供符合国际化质量标准的原液产品的生产。
在细胞培养工艺开发、原液工艺技术转移与放大、中试生产、GMP生产及质量管理等方面具有深厚的专业经验。
多年端到端生物制药产品CMC全生命周期管理经验，涵盖的技术路线包括单抗（mAb）、双特异抗体（bsAb）及抗体偶联药物（ADC）。
自2022年起担任ISPE中国生物制药分委员会核心成员，主导并参与多项ISPE活动的策划与执行，包括ISPE中国年会以及线上与线下分委员会活动。

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 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

马思睿