Webinar Overview

Regulatory bodies in the US and Europe are continuing to open up new accelerated pathways to approval in order to expedite access to innovative medicines. However, rapid regulatory approval does not necessarily translate to faster market access, and indeed, accelerated development timelines can result in a less robust data package available to payers at launch. In this webinar, we explore:

  • The key accelerated regulatory approval pathways available in the US and EU
  • The criteria used to evaluate candidates for acceptance into each accelerated approval scheme
  • Impact of each scheme on time to market vs. standard approval
  • Implications for market access – does faster time to market = faster time to access?
  • Case studies exploring how specific drugs that achieved rapid access have fared from an access perspective

 

 

Who Should Attend

  • Market Access
  • Commercial Planning/ New Product Planning
  • R&D Strategy/Project & Portfolio Planning
  • Regulatory Affairs
  • HEOR

Key Learning Objectives

  • Understand available accelerated regulatory schemes and criteria for use
  • Identify how accelerated regulatory access impacts market access
  • Understand, through case studies, the implications on HTA evaluations

Presenters

Susanne Michel, MD, Europe Practice Lead, Payer Strategy; Cheryl Ball US Practice Lead, Payer Strategy