2014 is described as the year of GDP Inspection readiness subject to the New EU guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01). The conference will address exactly that. The 3rd annual Cool Supply Systems and Solution 2014 will focus on your needs and solutions associated with trends for the next 12 to 18 months. GDP Inspectors from Belgium and Netherlands are on site to help and assist you with ‘corrective GDP interpretation’.
The management of temperature during the transportation of pharmaceutical products is undergoing a quiet revolution. What was considered to be a clear definition of ‘Cold Chain’ products is not subject to debate given the unprecedented changes in Regulatory and GDP Inspection requirements globally. And perhaps as the key leveraging point subject to the New EU guidelines on Good Distribution Practice of Medicinal Products for Human Use(2013/C 68/01). The New Act calls on all products to be Time and Temperature controlled; Ambient. Hence the making of the old ‘Cold Chain’ obsolete. A higher emphasis is placed on ‘systems management’ and a call for 24-7 monitoring and recordings to be adopted. As well as a key interest in demonstrating the where about of products at all times.
The handling of “cold chain” products and the increasing number of products that require temperature control is become much more tightly regulated across the entire pharma supply chain. These sessions will highlight the latest developments in the implementation phase of the EU GDP, the different interpretations within Europe and the latest work on harmonising regulations worldwide.
PharmaDialogue (The life sciences division of BusinessDialogue) spotted the new trend approximately 3 years ago; and as a direct result launched the Cool Supply System and Solutions. Also known as the Brussels Cool Chain network; where this new trend and emphasis could be put under scrutiny and engaged through practical discussions: and in-depth case studies. We now suggest a fundamental shift toward readiness for Good Distribution Practices to be the underlining focus for all players concerned with cool supply systems and solutions. There are several ‘Requirements’ interlinked to safe transport and storage of time and temperature controlled pharmaceutical shipments globally. IATA, WHO IPEC, ANMAT Ley 26.492 Regulation (Argentina), USP General Chapter 1079 to name few.
The Brussels Cool Chain network will address what links, what fundamentals and how various GDP requirements interlock. While the secondary focus will be on Logistics, Supply, Distribution, Transport, and Storage and underlining all of that will be addressing disruptions; Time and Temperature Excursions. Topics for 2014 range for ‘DATA’; Falsified Medicine, Supply Chain Integrity, new WHO technical report, IATA New Requirements, Eurasian Continent and Air Transport among others. Join 100+ cold chain professionals and engage to learn and apply cool chain logistics’ fail-safe techniques. Contacts by email, Tel or request to be contacted; we can tailor a package based on cost and time based on your specific needs. We look forward to hear from you…..