Próximo Webinar

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.

Regulatory Affairs Quality Assurance GMP China EU Market Access

miércoles, 29 de abril de 2026

TBD

Regulatory Affairs

Español

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.

¿Qué aprenderás?

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.

Aprende de los mejores

Ponentes

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

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

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

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.

¿Es para ti?

¿A quién va dirigido?

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

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