This 2-day Master Class brings together well-experienced experts to discuss the latest expectations and best practices for effective and efficient Supply Chain Oversight processes and how to get there.
Background
There is a steady increase in dependence on global supply chains. Pharmaceutical companies not only source starting materials from all over the world, but also outsource manufacturing activities. The finished products are then distributed globally. These complex supply chains with different transport routes and manufacturing locations lead to major challenges in terms of maintaining the quality of materials, intermediates and medicinal products.
This has increased the risk of potential compliance and delivery problems, having a negative impact on a company’s business and on the patient. Managing these supply chains and complying with GMP and GDP regulations require a comprehensive supply chain oversight with appropriate risk management measures.
The manufacturer, the Qualified Person (QP) but also the Responsible Person (RP) are primarily responsible for compliance with EU/EEA requirements:
EU-GMP Annex 16, General principles: “The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH).”
EU-GMP Annex 16, 1.7.2: “The entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP. This should include the manufacturing sites of the starting materials and packaging materials for the medicinal product and any other materials deemed critical through a risk assessment of the manufacturing process. The document should preferably be in the format of a comprehensive diagram…”
In the meantime, the competent authorities and inspectorates are also focusing on supply chain oversight processes; manufacturers and especially the marketing authorisation holder must know and control every level of the supply chain.
Target Group
QPs, RPs, Managers and Executives from pharmaceutical Quality and Supply Chain Units but also Senior Management, Business Executives and those involved in improving and controlling the pharmaceutical supply chain.
Date & Venue
Date Thursday, 26 June 2025, 9.00h – 17.00h (Registration and coffee 8.30h – 9.00h) Friday, 27 June 2025, 8.30h – 15.00h
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona, Spain Phone: +34 / 93 / 503 53 00 Email: sants@barcelo.com
Testimonials
Seminar Programme as PDF