QbD Group
    即将举办的网络研讨会

    EU-GMP Readiness and Supply Chain Strategies for Chinese Pharma

    This webinar is a practical guide for Chinese pharmaceutical manufacturers preparing for Europe. It explains how EU-GMP requirements apply across the manufacturing and supply chain lifecycle, how inspections and certifications influence timelines, and how to build a launch-ready setup that supports smooth QP release and uninterrupted supply.

    2026年4月29日星期三
    TBD
    Regulatory Affairs
    Chinese

    Europe represents one of the most attractive pharmaceutical markets globally, but for manufacturing-driven companies, access is determined less by ambition and more by operational readiness. EU authorities place strong emphasis on how products are manufactured, controlled, released, and distributed. For Chinese manufacturers, understanding how EU-GMP expectations extend beyond the production site into the broader supply chain is critical to achieving a successful and timely market entry.

    This webinar focuses on the manufacturing reality behind EU access: what European regulators and Qualified Persons (QPs) expect from production sites, how GMP readiness impacts registration and approval timelines, and how supply chain design can either accelerate or delay market entry.

    What you'll learn

    • How EU-GMP requirements impact Chinese manufacturing sites and how GMP readiness influences EU registration and approval timelines.
    • What European inspectors and QPs expect from manufacturers, including documentation, audits, QP Declarations, and supplier oversight.
    • How to prepare manufacturing sites and quality systems to support EU inspections without disrupting ongoing production.
    • How to design a compliant EU supply chain, including testing, warehousing, serialization, and distribution, aligned with manufacturing capabilities.
    • How early planning for batch certification and QP release can prevent delays at launch.
    • Practical examples of how manufacturers have successfully aligned production and supply chain operations for EU market access.

    向最优秀的人学习

    演讲者

    Three experts with deep experience in GMP compliance, CMC strategy, and EU market access for pharmaceutical manufacturers.

    Joanna Popiołkiewicz, PharmD

    Joanna Popiołkiewicz, PharmD

    Scientific and Business Development Director, QPPV at QbD Group

    Joanna Popiołkiewicz is Scientific and Business Development Director and QPPV with 20 years of experience in drug development consulting. She holds an MSc and PhD in pharmacy, with academic specialization in clinical analytics and molecular biology. Combining scientific expertise, regulatory knowledge, and strategic planning, Joanna drives successful development, registration, and launch of pharmaceutical products.
    Marta Klepczyńska

    Marta Klepczyńska

    Head of CMC Department & Qualified Person at QbD Group

    Marta Klepczyńska holds a master's degree in chemistry with postgraduate studies in industrial pharmacy. With 15 years of extensive experience in quality assurance, GMP/GLP audits, and management of CMC processes, she oversees CMC compliance with GMP standards and drives efficient development and release of pharmaceutical products.
    Joanna Rapacz

    Joanna Rapacz

    CMC and RA Director & Qualified Person at QbD Group

    Joanna Rapacz has over 25 years of experience in the pharmaceutical industry. She is responsible for regulatory affairs, CMC strategy, GMP quality oversight, and implementation, ensuring compliance across development and manufacturing processes.

    Is this for you?

    Who should attend?

    Manufacturing and site leaders at Chinese pharmaceutical companies planning EU market access

    Quality Assurance (QA) professionals responsible for GMP compliance, audits, and quality systems

    Quality Control (QC) managers involved in EU testing, method transfer, and release activities

    Supply chain and technical operations teams coordinating testing, warehousing, distribution, and serialization

    Professionals involved in EU QP coordination and batch certification

    Keep watching

    More webinars

    AI in Life Sciences: Session 2, Your Questions Answered 即将举办的网络研讨会

    AI in Life Sciences: Session 2, Your Questions Answered

    Software Solutions & Services2026年5月13日

    Adopting AI in life sciences holds enormous potential, but navigating GxP requirements adds real complexity. In this joint session, QbD Group and delaware walk you through how to deploy AI that is trustworthy, validated, and inspection-ready, covering data governance, explainability, and lifecycle management. Building on the first session, this edition dedicates more time to answering your questions, addressing the topics raised by the audience in Session 1, and opening the floor for live debate and discussion.

    立即注册

    我们使用 Cookie 来改善您的体验

    我们使用必要的 Cookie 来保证网站功能，以及可选的分析 Cookie 来改善我们的服务。 阅读我们的 隐私政策 和 Cookie 政策.