EU-GMP Readiness and Supply Chain Strategies for Chinese Pharma
A Practical Guide for Manufacturers Accessing the European Market
📅 Date: On Demand 🕐 Time: 60 min 🏷️ Topic: EU-GMP, Supply Chain, Quality Assurance 🌐 Language: English
About this webinar
For Chinese pharmaceutical companies with a strong focus on manufacturing, entering Europe requires more than regulatory approval. It demands end-to-end GMP and supply chain readiness, from API and finished product manufacturing to testing, batch certification, and distribution in the EU.
This webinar is designed as a practical guide for 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. The session combines regulatory expectations with operational realities, helping manufacturers translate EU requirements into actionable steps.
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
Speakers
This session brings together regulatory, CMC, and Qualified Person expertise to help Chinese manufacturers navigate EU-GMP readiness, batch certification, and supply chain design for the European market.
Joanna Popiołkiewicz, PharmD
Scientific and Business Development Director, QPPV at QbD Group
Joanna has 20 years of experience in drug development consulting, covering regulatory strategy oversight, preclinical and clinical development, and pharmacovigilance services. She holds an MSc and PhD in pharmacy with academic specialization in clinical analytics and molecular biology, and is the author of numerous scientific publications on biomedical research. Before joining QbD Group, she gained experience at the National Medicines Institute and Novartis in Clinical Trials.
Marta Klepczynska
Head of CMC Department & Qualified Person at QbD Group
Marta holds a master's degree in chemistry with postgraduate studies in industrial pharmacy and has 15 years of experience in quality assurance, GMP/GLP audits, and CMC process management. She began her career in quality control at Adamed Pharma before taking on leadership roles. As Head of the CMC Department and Qualified Person at QbD Group, she oversees CMC compliance and drives the development and release of pharmaceutical products.
Joanna Rapacz
CMC and RA Director & Qualified Person at QbD Group
Joanna has over 25 years of experience in the pharmaceutical industry, covering regulatory affairs, CMC strategy, GMP quality oversight, and implementation. She holds a master's degree in chemistry and has built her expertise across quality control, R&D, and regulatory compliance at leading pharmaceutical companies and institutes.
Who Should Attend
This webinar is built for teams driving EU market access from China-based manufacturing operations.
- 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