There is a saying, coined by the late Edward Lorenz, an early pioneer of the chaos theory, that “the flap of a butterfly’s wings in Brazil can set off a tornado in Texas.” This observation is known as the butterfly effect: the concept that small changes can have large downstream effects.
How has your company been preparing for EU MDR?
Minnie Baylor-Henry and Jon Lange discussed this topic during one of our most well attended webinars last month. If you missed the live event, you can now watch the recorded presentation below.
There is a heightened sense of urgency by all stakeholders to accelerate development of therapies for rare disease. The FDA shares this urgency, but it also must protect the public safety and follow the well-defined laws and regulations governing the process.
The challenge (or opportunity) is to develop creative approaches, which accelerate access and stay within the regulatory boundaries – or find ways to shape the boundaries. Intermediate Clinical Endpoints, or ICE, could represent one such approach.
While there has been much progress to harmonize EMA and FDA regulations for drug development, there are still areas where the respective agencies differ. And these differences can have a direct impact on pharmaceutical development planning.
To shed some light on the topic, on October 26th YourEncore assembled an all-star panel of industry experts after RAPS Convergence to share their inside perspectives on three particular areas of divergence/convergence: