Let’s Get This EVMPD Party Started

Welcome back to the EVMPD blog, and Happy New Year. 2012 is now under way and the EVMPD is no longer next year’s issue. It’s hammering on the door of almost every pharmaceutical and biotech company. With less than six months to D-Day, where are you in terms of preparation? Do you have a plan in place? Have you selected a team, started to search for and gather data, and prepare a temporary repository for placing the data until such time as a dedicated solution is made available?

There’s no doubting the EMA hasn’t made the task of getting ready easy with delays on providing information, guidance, and tools. Questions remain unanswered, or at least answers have not been widely distributed. The EVMPD web tool is still unavailable and will remain so for several more weeks. In September, the agency had said the tool would be available from February 1, but this has since been pushed back to sometime in February, but certainly not at the start of the month.

With feedback from EVMPD expert Andrew Marr that the DIA/EMA EVMPD training was off to a disappointing start, companies would rightly be wondering how they can be expected to be ready when the agency seems far from on top of things. Nevertheless, they must meet the EVMPD mandate. The months ahead will be tough, there’s no doubt. But as we start the New Year, let’s approach the EVMPD with a positive frame of mind, and a clear plan of action.