B21 Balancing post-market monitoring with pre-market requirements

There is an increasing international trend towards earlier regulatory approval. In the EU this is through adaptive pathways and in the US through expedited programmes. These mechanisms provide ways to address unmet clinical need in the treatment of serious or life-threatening conditions where a therapy is considered breakthrough. Along with earlier approval can come a higher level of uncertainty in terms of both safety and efficacy of the product that will require a higher level of post-market activity including post-market confirmatory trials and other intensive data collection.  The session will examine the challenges and opportunities for re-balancing pre and post-market activities in this new environment.

Chairperson: Judy Bingham, Easington and ARCS Director