网络研讨会直播
数据无界：中国临床证据用于EMA上市审评深度评估
2026.6.17 | 16:00 – 17:00
随着中国生物制药创新的加速发展，一个日益关键的问题应运而生：仅由中国或以中国为主的临床数据能否真正支持欧洲的上市批准？
虽然欧洲药品管理局（EMA）已展现出对外国数据的开放态度，但其接受标准正在不断演变，远非板上钉钉。关于数据质量、全球适用性、标准治疗方案和监管策略的期望变得越来越严格。
在这场由EMA多位前CHMP委员会成员组成的专家网络研讨会中，我们将深入探讨：中国生成的数据何时可以满足监管要求、何时存在不足，以及如何从一开始就设计符合欧洲要求的开发项目。基于最近的批准案例、监管先例和真实世界案例研究，我们将提供实用见解，帮助企业降低全球战略风险，避免代价高昂的返工。
立即报名参与我们的专家网络研讨会，掌握连接中国主导开发与欧盟市场成功准入的关键路径。
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专家阵容
主持人 – Sinan B. Sarac博士
精鼎医药监管咨询高级副总裁、欧洲肿瘤学部门负责人
Dr. Sinan B. Sarac has more than 10 years of experience within the EU regulatory system, including monthly interactions with FDA, Health Canada, Swiss Medic, PMDA, and other health/medicines authorities and agencies. He served at the European Medicines Agency (EMA) as a member of the Committee for Medicinal Products for Human Use (CHMP) for >6 years. He is member and Chair of CHMP’s Oncology Working Party (ONCWP). Dr. Sarac has also served as a member of the Committee for Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP) at the EMA. He has attended +100 meetings in CHMP, CAT, and SAWP, and countless Oral Explanations in CHMP and CAT.
At Parexel, he is responsible for providing strategic, clinical, and technical advice to clients, especially regarding clinical development strategy, marketing authorization, scientific advice submissions, pre-IND, IND, NDA, BLA, MAA, ODD, PRIME, Fast track, Breakthrough designation, high-stake FDA/EMA meetings, etc.
Aaron Sosa 博士
精鼎医药监管咨询肿瘤学技术副总裁
Dr. Aaron Sosa is a highly skilled Medical Oncologist and experienced EU regulator. He has proven track record within EU medicinal product regulation, including interactions with multiple medicine agencies and health authorities across the world; and was Chief Medical Officer of the Danish Medicines Agency +3 years. Dr. Sosa is member of EMA’s CHMP (Committee for Medicinal Products for Human Use) +3 years, overseeing an extensive portfolio of Oncology and Hematology products, and playing a key role in regulatory decisions. He is also member at EMA’s SAWP (Scientific Advice Working Party), providing expert guidance for the clinical development of cancer therapies.
Simona Stankeviciute博士
精鼎医药监管战略咨询临床技术副总裁
Dr. Simona Stankeviciute has rich clinical and regulatory R&D experience, with over 6 years of experience as a clinical assessor in the EMA, former CHMP alternate member. She has been with Parexel as a regulatory adviser for 5 years. Her expertise includes but not limited to: Regulatory and Product Development Strategy, Clinical Development Planning, FDA submissions, EMA submissions and Marketing Applications, Regulatory review and drug development experience in multiple indications.
Matthias Kruse博士
精鼎医药监管咨询临床药理学技术副总裁
Dr. Matthias Kruse has 27 years of medical & scientific expertise in early drug development (translational science, Phase I – II) as board certified Clinical Pharmacologist, with diversified experience in the areas of basic and advanced pharmacokinetics, pharmacodynamics, toxicology and bio–pharmaceutical methodologies. He used to be Clinician Internal Medicine. And he has broad experience in study design (protocols), dataanalysis and interpretation of results incl. preparation of clinical study reports and market application/submission documents. Dr. Kruse is member of the German Association for Applied Human Pharmacology.