White Paper Taps Regulatory Thought Leaders on Impact of EVMPD
The EVMPD is having a profound effect on the pharma and biotech industry. Companies have to confront many harsh realities regarding their product data, and make rapid decisions on how to proceed in order to meet the July 2 deadline.
During a recent forum, regulatory leaders from several major pharma companies discussed their own concerns, plans and strategies. As they made clear, it’s not just the near-term that companies are worrying about; in fact, for some, that’s the least of their concerns. According to one regulatory leader:
“The big concern here is just the sustainability. We’ll get to the July 2, 2012, mandate with something. We’re making an effort; we’ll have a plan, do our due diligence and ensure we have something. My major concern is what happens from July 3 — once we send that first submission to the EMA — in terms of sustaining the internal processes moving forward. How do we keep things in sync given that we need to start by taking a tactical approach in terms of creating some sort of staging area or warehouse for the EVMPD data? How then do we manage this strategically thereafter in terms of automating the data and managing new roles? Maintaining this going forward will be a challenge.”
To learn from those in the thick of the EVMPD requirement the how, why, where and what of one of the most broad-reaching regulatory changes in decades, read the exclusive white paper, titled: Eyes on July 2, 2012: Forum Explores Path to EVMPD.
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