IMI ADAPT SMART, IMI GetReal and MIT NEW Drug Development ParadIGmS (NEWDIGS) “Adaptive Design Laboratory” workshop
EventCorporate
Date
- Wednesday, 1 June 2016, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The format of this two-day workshop is based on the NEWDIGS 'scenario design' methodology which leverages case studies to facilitate open yet structured discussion among stakeholders from different sectors regarding scientific, regulatory and utilization issues; and how potential options for integrated evidence generation and use plans across the product life span might help resolve those issues. In this workshop, Day 1 will focus on a retrospective case and, in particular, explore options for how Real World Evidence might be used to bridge the efficacy to effectiveness gap. Day 2 will be a retrospective review of a product, exploring “what if” Adaptive Pathways had been available, what other scenarios might have emerged in terms of its development, licensing, and utilization.