Supply Chain of ATMPs - Online Training Recording

Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, represent a distinct class of medicinal products as defined under Regulation (EC) No 1394/2007 and are subject to specific regulatory, quality, and safety requirements. While these therapies offer significant therapeutic potential, their development and commercialization are associated with a high level of complexity throughout the entire supply chain. From donor collection or patient apheresis to manufacturing, quality control, storage, transport, regulatory release, and bedside administration, ATMPs challenge established pharmaceutical supply chain models.

The individualized nature of many ATMPs, particularly autologous therapies, results in small batch sizes, limited shelf life, and stringent requirements for temperature control, traceability, and segregation. Compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and applicable GxP guidelines necessitates strict implementation of chain of identity and chain of condition concepts to ensure product quality, patient safety, and regulatory compliance across all supply chain steps.

This event provides a structured overview of the ATMP supply chain, addressing scientific, technical, regulatory, and operational aspects in accordance with EU and international regulatory frameworks. It covers autologous, allogeneic, and in vivo gene therapies and examines how their specific characteristics influence logistics design, manufacturing strategies, and quality systems. Key topics include storage and transport temperature strategies, cryogenic versus non-cryogenic supply chains, regulatory challenges related to EU importation, Qualified Person (QP) release, dangerous goods classification under ADR/IATA, and the use of digital solutions to support traceability, monitoring, and orchestration.

The objective of this event is to provide participants with a comprehensive understanding of ATMP supply chain requirements and practical solutions. Through expert insights, real world case studies and experience reports from industry and treatment center, attendees will learn how to design scalable, compliant, and patient centric supply chains. The event aims to foster cross functional understanding, support informed decision making and encourage collaboration among stakeholders involved in bringing ATMPs safely and efficiently from vein to vein.