Current Trends in Global Distribution and Supply Chain
This article from Dave Dreifke discusses trends in GDP, including temperature excursion management, risk assessment, and temperature monitoring.
When working through the nuances of moving clinical supplies globally, my mind often wanders back to a scenario that occurred several years ago. During a meeting to determine a course of action to facilitate the customs release of clinical supplies in a South American country, a member of senior management entered the conference room to express disbelief in the possibility of supplies being held by customs authorities. “How can this occur? It’s simple, you grab the supplies, put them in a box, label it, put together a packing slip and you’re done.” Wow, don’t we wish it were that easy!
Some of you may have been in a situation, having survived a painful experience that left both yourself and your Study Team wondering if conducting a clinical trial in certain countries was actually worth it.
As an industry we have come a long way from the days of shipping supplies without much understanding of global governmental regulations and the assumed risk of sending supplies into international commerce. At the same time, governmental agencies have become increasingly aware of industry needs and have implemented reliable guidance, regulation and process change which have contributed to import/export procedures and the movement of commerce and clinical supplies.
In this piece, I’ll cover three new regulations related to clinical supply in the European Union and provide topline recommendations on managing their impact on your business. I’ll also provide thoughts on serialization, one of the hottest global topics to emerge since RFID was bantered around a decade ago.